K951450 is an FDA 510(k) clearance for the SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY. This device is classified as a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I - General Controls, product code KIJ).
Submitted by Strenumed, Inc. (Ventura, US). The FDA issued a Cleared decision on May 17, 1995, 49 days after receiving the submission on March 29, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K951450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1995 |
| Decision Date | May 17, 1995 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |