Sensus TPS Workstation— 510(k) K182665
Substantially EquivalentSensus Healthcare, Inc.
FDA 510(k) clearance K182665 for Sensus TPS Workstation, Substantially Equivalent on 2019-02-21. Applicant: Sensus Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Sensus Healthcare, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
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