Submission Details
| 510(k) Number | K123945 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 21, 2012 |
| Decision Date | April 17, 2013 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
STRIVE DUAL ZONE PEAK FLOW METER
Apr 2013
Decision
117d
Days
Class 2
Risk
About This 510(k) Submission
K123945 is an FDA 510(k) clearance for the STRIVE DUAL ZONE PEAK FLOW METER, 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 April 17, 2013, 117 days after receiving the submission on December 21, 2012. 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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