510(k) K050980
K050980 is an FDA 510(k) premarket notification submitted by Paradigm Medical Industries, Inc. for the device "ULTRASONIC BIO-MICROSCOPE, MODEL P60". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Paradigm Medical Industries, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2005
- Date Received
- April 19, 2005
- 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