Submission Details
| 510(k) Number | K964130 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1996 |
| Decision Date | January 10, 1997 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
AEROGEAR ASTHMA ACTION KIT
Jan 1997
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K964130 is an FDA 510(k) clearance for the AEROGEAR ASTHMA ACTION KIT, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on January 10, 1997, 87 days after receiving the submission on October 15, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.
Device Classification
| Product Code | BZH — Meter, Peak Flow, Spirometry |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1860 |
Manufacturer
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