Submission Details
| 510(k) Number | K023097 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 2002 |
| Decision Date | March 07, 2003 |
| Days to Decision | 170 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Abbreviated
TRUEZONE PEAK FLOW METER
Mar 2003
Decision
170d
Days
Class 2
Risk
About This 510(k) Submission
K023097 is an FDA 510(k) clearance for the TRUEZONE 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 March 7, 2003, 170 days after receiving the submission on September 18, 2002. 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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