DIGITAL NUCLEAR IMAGING SYSTEM— 510(k) K875198
Substantially EquivalentMedasys, Inc.
FDA 510(k) clearance K875198 for DIGITAL NUCLEAR IMAGING SYSTEM, Substantially Equivalent on 1988-07-01. Applicant: Medasys, Inc.. Device class: 1.
Clearance details
- Applicant
- Medasys, Inc.
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
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