The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Onestep Pediatric Cpr Multi-function Electrode.
| Device ID | K150055 |
| 510k Number | K150055 |
| Device Name: | OneStep Pediatric CPR Multi-Function Electrode |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | BIO-DETEK, INC. 525 NARRAGANSETT PARK DR Pawtucket, RI 02861 |
| Contact | Chuck Kolifrath |
| Correspondent | Tanmay Shukla 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 | 2015-01-12 |
| Decision Date | 2015-05-02 |
| Summary: | summary |