510(k) K021497
K021497 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "CYPRESS ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 2002. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Acuson Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2002
- Date Received
- May 9, 2002
- Clearance Type
- Special
- 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