510(k) K914862
K914862 is an FDA 510(k) premarket notification submitted by Medasonics, Inc. for the device "CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS". The FDA issued a decision of Substantially Equivalent on December 3, 1992. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Medasonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1992
- Date Received
- October 29, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type