The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for External Pediatric Defibrillator Paddle.
| Device ID | K842667 |
| 510k Number | K842667 |
| Device Name: | EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Contact | Richard E Fleeharty |
| Correspondent | Richard E Fleeharty MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-08-27 |