510(k) K930964
K930964 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)". The FDA issued a decision of Substantially Equivalent on October 26, 1994. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Acuson Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1994
- Date Received
- February 24, 1993
- 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