FDA.reportPublic FDA data

PMA P200044S002

Device
LungFit PH
Applicant
Beyond Air, Inc.
PMA number
P200044
Supplement
S002
Product code
QTB
Decision date
2023-04-21
Classification
Anesthesiology
Generic name
Nitric Oxide Generator and Delivery System
Approval order statement
Approval for an update to Pre-Use Guide (20092-01) to include a figure for bagging system connections which is already included in the Operator’s Manual and included in training.

Current openFDA PMA Record#

Device
LungFit PH
Applicant
Beyond Air, Inc.
PMA number
P200044
Supplement
S002
Product code
QTB
Generic name
Nitric Oxide Generator and Delivery System
Decision date
2023-04-21
Decision code
APPR
Date received
2023-03-24
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for an update to Pre-Use Guide (20092-01) to include a figure for bagging system connections which is already included in the Operator’s Manual and included in training.