The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Responder 2500 Defibrillator And Cardiac Care System.
| Device ID | K963120 |
| 510k Number | K963120 |
| Device Name: | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1997-02-28 |
| Summary: | summary |