K981776 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X. 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 August 3, 1998, 75 days after receiving the submission on May 20, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K981776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1998 |
| Decision Date | August 03, 1998 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |