510(k) K002766
K002766 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical for the device "NICOLET VASOGUARD". The FDA issued a decision of Substantially Equivalent on November 30, 2000. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Nicolet Biomedical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2000
- Date Received
- September 5, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 870.2880
- Review Panel
- CV
- Submission Type