The following data is part of a premarket notification filed by Bc Group International, Inc with the FDA for Defibrillator Analyzer Variable Load.
| Device ID | K153210 |
| 510k Number | K153210 |
| Device Name: | Defibrillator Analyzer Variable Load |
| Classification | Tester, Defibrillator |
| Applicant | BC GROUP INTERNATIONAL, INC 3081 ELM POINT INDUSTRIAL DRIVE Saint Charles, MO 63301 |
| Contact | Mel Roche |
| Correspondent | Mel Roche BC GROUP INTERNATIONAL, INC 3081 ELM POINT INDUSTRIAL DRIVE Saint Charles, MO 63301 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863313000330 | K153210 | 000 |
| 00863313000323 | K153210 | 000 |