The following data is part of a premarket notification filed by Med Air Technology, Inc. with the FDA for Adjustable Peep Valve.
Device ID | K872202 |
510k Number | K872202 |
Device Name: | ADJUSTABLE PEEP VALVE |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
Applicant | MED AIR TECHNOLOGY, INC. 2519 E. KEARNEY Springfield, MO 65803 |
Contact | Lois A Hansen |
Correspondent | Lois A Hansen MED AIR TECHNOLOGY, INC. 2519 E. KEARNEY Springfield, MO 65803 |
Product Code | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-09-01 |