K914271 is an FDA 510(k) clearance for the GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F). This device is classified as a Regulator, Pressure, Gas Cylinder (Class I - General Controls, product code CAN).
Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on April 13, 1992, 202 days after receiving the submission on September 24, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K914271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1991 |
| Decision Date | April 13, 1992 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAN — Regulator, Pressure, Gas Cylinder |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.2700 |