510(k) K022153
K022153 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "BLADDERSCAN BVI 6100". The FDA issued a decision of Substantially Equivalent on August 15, 2002. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2002
- Date Received
- July 2, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type