Primary Relief
FDA 510(k) clearance K213188 · decided 2022-01-31
Clearance details
- K-number
- K213188
- Device name
- Primary Relief
- Applicant
- Dyansys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-29
- Decision date
- 2022-01-31
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- NHI
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.