Prism
FDA 510(k) clearance K222101 · decided 2023-03-17
Clearance details
- K-number
- K222101
- Device name
- Prism
- Applicant
- Graymatters Health , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-18
- Decision date
- 2023-03-17
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- HCC
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Haifa, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.