GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR— 510(k) K854499
Substantially EquivalentGendex Corp.
FDA 510(k) clearance K854499 for GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR, Substantially Equivalent on 1986-04-22. Applicant: Gendex Corp.. Device class: 1.
Clearance details
- Applicant
- Gendex Corp.
- 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
- Franklin Park, IL, US
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