K791848 is an FDA 510(k) clearance for the RESPIROMETER MANIFOLD M-505. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).
Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979, 12 days after receiving the submission on September 19, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.
| 510(k) Number | K791848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1979 |
| Decision Date | October 01, 1979 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYX — Tubing, Pressure And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5860 |