The following data is part of a premarket notification filed by Bc Group International, Inc with the FDA for Defibrillator Analyzer - Da-2006p.
| Device ID | K110192 |
| 510k Number | K110192 |
| Device Name: | DEFIBRILLATOR ANALYZER - DA-2006P |
| Classification | Tester, Defibrillator |
| Applicant | BC GROUP INTERNATIONAL, INC 2913 209TH LANE NW Oak Grove, MN 55011 |
| Contact | Jack Slovick |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863313000354 | K110192 | 000 |
| 00863313000347 | K110192 | 000 |
| 00863313000316 | K110192 | 000 |
| 00863313000309 | K110192 | 000 |