SMARTDOP XT— 510(k) K131623
Substantially EquivalentKoven Technology, Inc.
FDA 510(k) clearance K131623 for SMARTDOP XT, Substantially Equivalent on 2014-01-17. Applicant: Koven Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Koven Technology, Inc.
- Product code
- Code JOP
- Device class
- Class 2
- Regulation
- 21 CFR 870.2880
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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