The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette 1200 Defibrillation Pads.
| Device ID | K895651 |
| 510k Number | K895651 |
| Device Name: | MARQUETTE 1200 DEFIBRILLATION PADS |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MARQUETTE ELECTRONICS, INC. 8 BALLO DRIVE, BALLOO INDUS. ESTATE, BANGOR, CO. DOWN, N. Ireland Bt19 2qy, GB |
| Contact | Omar Beggs |
| Correspondent | Omar Beggs MARQUETTE ELECTRONICS, INC. 8 BALLO DRIVE, BALLOO INDUS. ESTATE, BANGOR, CO. DOWN, N. Ireland Bt19 2qy, GB |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-12-12 |