The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Pad Pro Pediatric Electrode, Model Pad Pro 2602.
| Device ID | K002280 |
| 510k Number | K002280 |
| Device Name: | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDICAL DEVICES, INC. 2500 BELL AVE. Des Moines, IA 50321 |
| Contact | Warren R Walters |
| Correspondent | Warren R Walters MEDICAL DEVICES, INC. 2500 BELL AVE. Des Moines, IA 50321 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-26 |
| Decision Date | 2001-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405077630 | K002280 | 000 |
| 20653405042744 | K002280 | 000 |
| 20653405042645 | K002280 | 000 |
| 20653405042546 | K002280 | 000 |
| 20653405040108 | K002280 | 000 |