STarFix Designer Software C0265
FDA 510(k) clearance K231141 · decided 2023-09-08
Clearance details
- K-number
- K231141
- Device name
- STarFix Designer Software C0265
- Applicant
- FHC, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-21
- Decision date
- 2023-09-08
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- QRI
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bowdoin, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.