510(k) K903026
K903026 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "ES-1000SP II SMART DOP". The FDA issued a decision of Substantially Equivalent on February 26, 1991. 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
- February 26, 1991
- Date Received
- July 10, 1990
- 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