510(k) K922669
K922669 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW". The FDA issued a decision of Substantially Equivalent on January 29, 1993. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Koven and Assoc., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1993
- Date Received
- June 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type