STRATA, MODEL V.O.95— 510(k) K981678
Substantially EquivalentRosses Medical Systems
FDA 510(k) clearance K981678 for STRATA, MODEL V.O.95, Substantially Equivalent on 1998-12-11. Applicant: Rosses Medical Systems. Device class: 2.
Clearance details
- Applicant
- Rosses Medical Systems
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jessup, MD, US
Recent devices under product code MUJ
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