K852649 is an FDA 510(k) clearance for the PRESSURE REGULATOR/Y CONNECTOR. This device is classified as a Regulator, Pressure, Gas Cylinder (Class I - General Controls, product code CAN).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on August 2, 1985, 42 days after receiving the submission on June 21, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K852649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1985 |
| Decision Date | August 02, 1985 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAN — Regulator, Pressure, Gas Cylinder |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.2700 |