Harmony— 510(k) K182376
Substantially EquivalentTopcon Medical Systems, Inc.
FDA 510(k) clearance K182376 for Harmony, Substantially Equivalent on 2018-09-28. Applicant: Topcon Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Topcon Medical Systems, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Oakland, NJ, US
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