Submission Details
| 510(k) Number | K991212 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 09, 1999 |
| Decision Date | July 01, 1999 |
| Days to Decision | 83 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Abbreviated
MODIFICATION TO TRUZONE PEAK FLOW METER
Jul 1999
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K991212 is an FDA 510(k) clearance for the MODIFICATION TO TRUZONE 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 July 1, 1999, 83 days after receiving the submission on April 9, 1999. 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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