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 |