The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Aerogear Asthma Action Kit.
| Device ID | K964130 |
| 510k Number | K964130 |
| Device Name: | AEROGEAR ASTHMA ACTION KIT |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 Plattsburgh, NY 12901 |
| Contact | James A Cochie |
| Correspondent | James A Cochie MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 Plattsburgh, NY 12901 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-01-10 |
| Summary: | summary |