FDA Approved Fingertip Pulse Oximeter A330 Dual Color OLED

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FDA Approved Fingertip Pulse Oximeter A330 Dual Color OLED Anti-Movement - how consumers can search if the Fingertip Pulse Oximeter they would like to purchase and use is FDA Approved and safe to use.

FDA approval of medical devices means that the panel of judges of FDA advisory committee have determined that the benefits of device/devices outweigh the known risks for intended use by evaluation of clinical studies submitted in the marketing application, whether the application is approvable under the statutory requirements. If approved, the medical device can be marketed. However, FDA may consider clinical studies inadequate, data inadequate, in which case medical device cannot be marketed and a new marketing application needs to be submitted to FDA to determine, if the applicants product meets marketing requirements. 

Consumers can search the following web link to find out when the medical device was FDA cleared and officially approved. 

Devices@FDA

or visit 

https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

Once on Devices@FDA Database web page, in the search box

Enter a search term in the space below. 

Type the exact name of the medical device click search.

The name of device, name of company, approval date and the 510(k) number will appear in the search box. The 510(k) number is assigned by FDA to each application submitted for approval.

FDA medical device classes

Class I

Class II

Class III

Class I is considered low risk

Class II is considered low to medium risk

Class III is considered high risk.

What is  510(K)

 What is Substantial Equivalence 

What is Premarket Approval (PMA) 

Consumers to appreciate the cost spent for FDA approval of Medical devices

Consumers can be assured the quality of Medical Devices by 

Quality Systems Regulation 

Medical Devices

21 CFR Part 820 

Current Good Manufacturing Practice (CGMP) requirements are set forth in 

Quality Systems Regulation

Revised as of Friday, February 2, 2024 

Department of Health and Human Services FDA

Click below: 

Consumers to know the Design Control Guidance and requirements for Medical Device Manufactures of any class III or class II and the class I. FDA establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation most appropriate for their own design development processes and that they are consistent with quality system requirements worldwide.

Consumers may find significant change in the design of medical device that they have used. Click here to know proposed  changes to the device or the manufacturing process.

Click below: 

Consumers to know how FDA controls quality and safety of Medical Devices 

Above facts are based on search from FDA Database

 https://www.fda.gov 

At Global Medical and Computer Technology, we have been providing high-quality products to our customers. Our mission is to provide our customers with best quality products at an affordable price.