SYMPHONY OCT System
FDA 510(k) clearance K233366 · decided 2023-11-09
Clearance details
- K-number
- K233366
- Device name
- SYMPHONY OCT System
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2023-10-02
- Decision date
- 2023-11-09
- Days to decision
- 38 days
- Clearance type
- Special
- Product code
- NKG
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Le Locle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.