The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Monaghan Aerochamber.
Device ID | K822437 |
510k Number | K822437 |
Device Name: | MONAGHAN AEROCHAMBER |
Classification | Mouthpiece, Breathing |
Applicant | MONAGHAN MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BYP |
CFR Regulation Number | 868.5620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-13 |
Decision Date | 1982-11-03 |