IM512P— 510(k) K945792
Substantially EquivalentGlobus Industries
FDA 510(k) clearance K945792 for IM512P, Substantially Equivalent on 1995-05-24. Applicant: Globus Industries. Device class: 1.
Clearance details
- Applicant
- Globus Industries
- 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
- Holmdel, NJ, US
Recent devices under product code IYX
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