K864964 is an FDA 510(k) clearance for the 5 - IN - 1 CONNECTOR. This device is classified as a Tubing, Noninvasive (Class II - Special Controls, product code GAZ).
Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 20, 1987, 29 days after receiving the submission on December 22, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K864964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1986 |
| Decision Date | January 20, 1987 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GAZ — Tubing, Noninvasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |