The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Onestep Cpr Ii Multi-function Electrode.
| Device ID | K133441 |
| 510k Number | K133441 |
| Device Name: | ONESTEP CPR II MULTI-FUNCTION ELECTRODE |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | BIO-DETEK, INC. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Shannon Duhamel |
| Correspondent | Shannon Duhamel BIO-DETEK, INC. 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 | 2013-11-12 |
| Decision Date | 2014-10-10 |
| Summary: | summary |