K770136 is an FDA 510(k) clearance for the DISPOSABLE BACTERIA FILTER. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Omnicon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 14, 1977, 21 days after receiving the submission on January 24, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K770136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1977 |
| Decision Date | February 14, 1977 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |