K040723 is an FDA 510(k) clearance for the MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE). This device is classified as a Meter, Peak Flow, Spirometry (Class II - Special Controls, product code BZH).
Submitted by Microlife Intellectual Property GmbH (Great Neck, US). The FDA issued a Cleared decision on June 10, 2004, 80 days after receiving the submission on March 22, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1860.
| 510(k) Number | K040723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2004 |
| Decision Date | June 10, 2004 |
| Days to Decision | 80 days |
| Submission Type | Abbreviated |
| 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 |