IMAGE STORAGE SYSTEM, MODEL KSS-400— 510(k) K081797
Substantially EquivalentKonan Medical, Inc.
FDA 510(k) clearance K081797 for IMAGE STORAGE SYSTEM, MODEL KSS-400, Substantially Equivalent on 2009-01-22. Applicant: Konan Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Konan Medical, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hasbrouck Heights, NJ, US
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