K940055 is an FDA 510(k) clearance for the MULTISET. This device is classified as a Set, Blood Transfusion (Class II - Special Controls, product code BRZ).
Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on April 15, 1994, 100 days after receiving the submission on January 5, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K940055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1994 |
| Decision Date | April 15, 1994 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | BRZ — Set, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |