K013133 is an FDA 510(k) clearance for the NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116. This device is classified as a Battery, Replacement, Rechargeable (Class I - General Controls, product code MOQ).
Submitted by Nordix, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 13, 2001, 55 days after receiving the submission on September 19, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K013133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2001 |
| Decision Date | November 13, 2001 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MOQ — Battery, Replacement, Rechargeable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |