510(k) K943200
K943200 is an FDA 510(k) premarket notification submitted by Advance Medical Device, Inc. for the device "FLOSCOPE SUPER VASCULAR LAB". The FDA issued a decision of Substantially Equivalent on November 21, 1995. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Advance Medical Device, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1995
- Date Received
- July 5, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Nonfetal
- Device Class
- Class II
- Regulation Number
- 892.1540
- Review Panel
- RA
- Submission Type