K955234 is an FDA 510(k) clearance for the TRUPEAK PEAK FLOW METER. This device is classified as 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 March 18, 1996, 125 days after receiving the submission on November 14, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1860.
| 510(k) Number | K955234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1995 |
| Decision Date | March 18, 1996 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZH — Meter, Peak Flow, Spirometry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1860 |