PANTHER REALART, MODEL 4.7— 510(k) K083502
Substantially EquivalentProwess, Inc.
FDA 510(k) clearance K083502 for PANTHER REALART, MODEL 4.7, Substantially Equivalent on 2009-05-05. Applicant: Prowess, Inc.. Device class: 2.
Clearance details
- Applicant
- Prowess, 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
- Concord, CA, US
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