K781922 is an FDA 510(k) clearance for the PULMONARY MONITOR. This device is classified as a Meter, Peak Flow, Spirometry (Class II - Special Controls, product code BZH).
Submitted by Vitalograph , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1979, 92 days after receiving the submission on November 13, 1978.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1860.
| 510(k) Number | K781922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1978 |
| Decision Date | February 13, 1979 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | BZH - Meter, Peak Flow, Spirometry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1860 |