510(k) K874854
K874854 is an FDA 510(k) premarket notification submitted by Labsonics, Inc. for the device "GPS/WGPS/PREVIEW GP". The FDA issued a decision of Substantially Equivalent on August 25, 1988. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Labsonics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1988
- Date Received
- November 27, 1987
- 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