FDA.reportPublic FDA data

PMA P200044S003

Device
LungFit PH
Applicant
Beyond Air, Inc.
PMA number
P200044
Supplement
S003
Product code
QTB
Decision date
2023-09-10
Classification
Anesthesiology
Generic name
Nitric Oxide Generator and Delivery System
Approval order statement
Approval for minor software changes to add support for future language translations, enhance manfucaturability and serviceability, refine alarms, limit the range for date changes, and for preparation of future compatibility and enhancements.

Current openFDA PMA Record#

Device
LungFit PH
Applicant
Beyond Air, Inc.
PMA number
P200044
Supplement
S003
Product code
QTB
Generic name
Nitric Oxide Generator and Delivery System
Decision date
2023-09-10
Decision code
APPR
Date received
2023-05-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor software changes to add support for future language translations, enhance manfucaturability and serviceability, refine alarms, limit the range for date changes, and for preparation of future compatibility and enhancements.