LIFESYNE SYSTEMS
FDA 510(k) clearance K030795 · decided 2003-08-05
Clearance details
- K-number
- K030795
- Device name
- LIFESYNE SYSTEMS
- Applicant
- Gmp/Companies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-12
- Decision date
- 2003-08-05
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for us recall (Z-1659-2008) | Lifesync Corporation | 2008-09-16 |
| LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as recall (Z-1660-2008) | Lifesync Corporation | 2008-09-16 |
| LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 recall (Z-0546-2007) | GMP Companies/Lifesync Corporation | 2007-02-27 |