K822216 is an FDA 510(k) clearance for the VOLUMETRIC CONTROLLER. This device is classified as a Bag, Reservoir (Class I - General Controls, product code BTC).
Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982, 21 days after receiving the submission on July 26, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5320.
| 510(k) Number | K822216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1982 |
| Decision Date | August 16, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTC — Bag, Reservoir |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5320 |