510(k) K923211
K923211 is an FDA 510(k) premarket notification submitted by Zeiss Humphrey System for the device "DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE". The FDA issued a decision of Substantially Equivalent on November 8, 1993. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Zeiss Humphrey System has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1993
- Date Received
- July 1, 1992
- 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