K772295 is an FDA 510(k) clearance for the INSPIRON MANIFOLD (SINGLE). This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1978, 35 days after receiving the submission on December 13, 1977.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K772295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1977 |
| Decision Date | January 17, 1978 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |