K963120 is an FDA 510(k) clearance for the RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM. This device is classified as a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II - Special Controls, product code DRO).
Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 28, 1997, 200 days after receiving the submission on August 12, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5550.
| 510(k) Number | K963120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1996 |
| Decision Date | February 28, 1997 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5550 |