K791912 is an FDA 510(k) clearance for the IMV FOR MONITORING #M-510. This device is classified as a Attachment, Intermittent Mandatory Ventilation (imv) (Class II - Special Controls, product code CBO).
Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1979, 14 days after receiving the submission on September 25, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5955.
| 510(k) Number | K791912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1979 |
| Decision Date | October 09, 1979 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBO — Attachment, Intermittent Mandatory Ventilation (imv) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5955 |