K811991 is an FDA 510(k) clearance for the SIMVAC. This device is classified as a Attachment, Intermittent Mandatory Ventilation (imv) (Class II - Special Controls, product code CBO).
Submitted by The Lynn Terrell Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981, 30 days after receiving the submission on July 13, 1981.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5955.
| 510(k) Number | K811991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1981 |
| Decision Date | August 12, 1981 |
| Days to Decision | 30 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 |