K932147 is an FDA 510(k) clearance for the NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE. This device is classified as a Mask, Gas, Anesthetic (Class I - General Controls, product code BSJ).
Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 20, 1993, 108 days after receiving the submission on May 4, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5550.
| 510(k) Number | K932147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1993 |
| Decision Date | August 20, 1993 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BSJ — Mask, Gas, Anesthetic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5550 |