Submission Details
| 510(k) Number | K031514 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 14, 2003 |
| Decision Date | May 23, 2003 |
| Days to Decision | 9 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Special
MODIFICATION TO TRUPEAK PEAK FLOW METER
May 2003
Decision
9d
Days
Class 2
Risk
About This 510(k) Submission
K031514 is an FDA 510(k) clearance for the MODIFICATION TO TRUPEAK 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 May 23, 2003, 9 days after receiving the submission on May 14, 2003. 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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