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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLungFit PH
Generic NameNitric Oxide Generator and Delivery System
ApplicantBeyond Air, Inc.
825 E. Gate Blvd., Suite 320
Garden City, NY 11530
PMA NumberP200044
Supplement NumberS004
Date Received06/30/2023
Decision Date09/29/2023
Product Code QTB 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of a minor hardware change to allow the user to increase the alarm volume by moving a mechanical slider on the backside of the LungFit PH display.
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