K946077 is an FDA 510(k) clearance for the DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on September 15, 1995, 276 days after receiving the submission on December 13, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K946077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1994 |
| Decision Date | September 15, 1995 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZC — Calculator, Pulmonary Function Data |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1880 |