EEG-acp
FDA 510(k) clearance K212325 · decided 2022-06-15
Clearance details
- K-number
- K212325
- Device name
- EEG-acp
- Applicant
- Somnomedics GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-07-26
- Decision date
- 2022-06-15
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- GYB
- Device class
- 2
- Regulation number
- 882.1275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Randersacker, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.