Submission Details
| 510(k) Number | K030586 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2003 |
| Decision Date | August 27, 2003 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
MICROPEAK
Aug 2003
Decision
184d
Days
Class 2
Risk
About This 510(k) Submission
K030586 is an FDA 510(k) clearance for the MICROPEAK, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Micro Direct, Inc. (Lewiston, US). The FDA issued a Cleared decision on August 27, 2003, 184 days after receiving the submission on February 24, 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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