K973851 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on January 5, 1998, 89 days after receiving the submission on October 8, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K973851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1997 |
| Decision Date | January 05, 1998 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |