MODEL MPFT-01, GENESIS— 510(k) K934574
Substantially EquivalentInternational Medical Designs, Inc.
FDA 510(k) clearance K934574 for MODEL MPFT-01, GENESIS, Substantially Equivalent on 1994-03-04. Applicant: International Medical Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- International Medical Designs, Inc.
- Product code
- Code IXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deltona, FL, US
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