K914980 is an FDA 510(k) clearance for the HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).
Submitted by Medical Fittings, Inc. (Northampton, US). The FDA issued a Cleared decision on January 21, 1992, 76 days after receiving the submission on November 6, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.
| 510(k) Number | K914980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1991 |
| Decision Date | January 21, 1992 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYX — Tubing, Pressure And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5860 |