ORBITOME-UG— 510(k) K780319
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K780319 for ORBITOME-UG, Substantially Equivalent on 1978-03-14. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Product code
- Code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code IZF
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