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 |