Dome Electrode
FDA 510(k) clearance K190416 · decided 2019-04-04
Clearance details
- K-number
- K190416
- Device name
- Dome Electrode
- Applicant
- Coapt, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-02-21
- Decision date
- 2019-04-04
- Days to decision
- 42 days
- Clearance type
- Abbreviated
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Coapt Dome Electrode, Gen2 system, cutaneous electrode recall (Z-0203-2024) | Coapt LLC | 2023-10-31 |