Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
FDA 510(k) clearance K213972 · decided 2022-02-17
Clearance details
- K-number
- K213972
- Device name
- Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
- Applicant
- Ge Healthcare Information Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-20
- Decision date
- 2022-02-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wauwatosa, WI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, use recall (Z-2613-2023) | GE Medical Systems Information Technologies Inc | 2023-09-19 |