MAC-LAB/CARDIOLAB EP/COMBOLAB
FDA 510(k) clearance K021366 · decided 2002-07-03
Clearance details
- K-number
- K021366
- Device name
- MAC-LAB/CARDIOLAB EP/COMBOLAB
- Applicant
- General Electric Medical Systems Information Techn
- Decision
- Substantially Equivalent
- Date received
- 2002-04-30
- Decision date
- 2002-07-03
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAC-LAB 1000EX systems recall (Z-0783-03) | General Electric Medical Systems Information Technology | 2003-04-25 |