HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR— 510(k) K851011
Substantially EquivalentHofmann X-Ray of America, Inc.
FDA 510(k) clearance K851011 for HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR, Substantially Equivalent on 1985-04-10. Applicant: Hofmann X-Ray of America, Inc.. Device class: 1.
Clearance details
- Applicant
- Hofmann X-Ray of America, Inc.
- Product code
- Code IZO
- Device class
- Class 1
- Regulation
- 21 CFR 892.1700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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