The following data is part of a premarket notification filed by Datrend Systems, Inc. with the FDA for Phase 3, Model Dt-1.
| Device ID | K062099 |
| 510k Number | K062099 |
| Device Name: | PHASE 3, MODEL DT-1 |
| Classification | Tester, Defibrillator |
| Applicant | DATREND SYSTEMS, INC. 3531 JACOMBS RD., UNIT 1 Richmond, British Columbia, CA V6v 1z8 |
| Contact | Ron Evans |
| Correspondent | Ron Evans DATREND SYSTEMS, INC. 3531 JACOMBS RD., UNIT 1 Richmond, British Columbia, CA V6v 1z8 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2007-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B418PHASE380004400 | K062099 | 000 |