PENN-PET SCANNER— 510(k) K890100
Substantially EquivalentUgm Medical Systems, Inc.
FDA 510(k) clearance K890100 for PENN-PET SCANNER, Substantially Equivalent on 1989-04-13. Applicant: Ugm Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ugm Medical Systems, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, PA, US
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