FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
FDA 510(k) clearance K011901 · decided 2002-02-01
Clearance details
- K-number
- K011901
- Device name
- FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
- Applicant
- Survivalink Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-18
- Decision date
- 2002-02-01
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Power Heart AED Automatic External Defibrillator, Model 9200 RD recall (Z-1033-04) | Cardiac Science, Inc. | 2004-07-20 |
| Power Heart Automatic External Defibrillator, Model 9210 RD recall (Z-1034-04) | Cardiac Science, Inc. | 2004-07-20 |