PHASE 3, MODEL DT-1
FDA 510(k) clearance K062099 · decided 2007-01-25
Clearance details
- K-number
- K062099
- Device name
- PHASE 3, MODEL DT-1
- Applicant
- Datrend Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-24
- Decision date
- 2007-01-25
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- DRL
- Device class
- 2
- Regulation number
- 870.5325
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Richmond, British Columbia, CA
- Third-party review
- No
- Expedited review
- No
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| IMPULSE 3000 DEFIBRILLATOR ANALYZER (K934254) | Dynatech/Nevada, Inc. | 1993-11-23 |
Recalls involving this device
No recalls on record reference this clearance.