K993120 is an FDA 510(k) clearance for the MODIFIED BLOOD RECIPIENT SET. This device is classified as a Set, Blood Transfusion (Class II - Special Controls, product code BRZ).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 17, 1999, 58 days after receiving the submission on September 20, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K993120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1999 |
| Decision Date | November 17, 1999 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | BRZ — Set, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |