K000685 is an FDA 510(k) clearance for the CHARTER MEDICAL NEONATAL SYRINGE SET. This device is classified as a Set, Blood Transfusion (Class II - Special Controls, product code BRZ).
Submitted by Charter Medical, Ltd. (Lakewood, US). The FDA issued a Cleared decision on August 15, 2000, 168 days after receiving the submission on February 29, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K000685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2000 |
| Decision Date | August 15, 2000 |
| Days to Decision | 168 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 |