SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR— 510(k) K920333
Substantially EquivalentKoven and Assoc., Inc.
FDA 510(k) clearance K920333 for SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR, Substantially Equivalent on 1993-01-22. Applicant: Koven and Assoc., Inc.. Device class: 2.
Clearance details
- Applicant
- Koven and Assoc., Inc.
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code DPW
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