The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Cpr Dura-padz Reusable Defibrillation Electrode With Dura-padz Gel.
| Device ID | K150198 |
| 510k Number | K150198 |
| Device Name: | CPR Dura-Padz Reusable Defibrillation Electrode With Dura-padz Gel |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | Bio-Detek, Inc. 525 Narragansett Park Drive Pawtucket, RI 02861 |
| Contact | Chuck Kolifrath |
| Correspondent | Shannon Duhamel ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-29 |
| Decision Date | 2015-05-02 |
| Summary: | summary |