510(k) K811316
K811316 is an FDA 510(k) premarket notification submitted by Visidyne Corp. for the device "TRISCAN, MODELS 38,40,41,43 & 45". The FDA issued a decision of Substantially Equivalent on July 2, 1981. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Visidyne Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1981
- Date Received
- May 12, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type