K972746 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on October 21, 1997, 90 days after receiving the submission on July 23, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K972746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1997 |
| Decision Date | October 21, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |