K770183 is an FDA 510(k) clearance for the O.22/UM FILTERSET W/FLASHBACK. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 9, 1977, 13 days after receiving the submission on January 27, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K770183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1977 |
| Decision Date | February 09, 1977 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |