TOMi Scope— 510(k) K191804
Substantially EquivalentPhotonicare, Inc.
FDA 510(k) clearance K191804 for TOMi Scope, Substantially Equivalent on 2019-12-05. Applicant: Photonicare, Inc.. Device class: 2.
Clearance details
- Applicant
- Photonicare, Inc.
- Product code
- Code QJG
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Champaign, IL, US
Recent devices under product code QJG
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