510(k) K800139
K800139 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "SEARLE PHO/SONIC ALPHA 2000". The FDA issued a decision of Substantially Equivalent on Feb 11, 1980. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 1980
- Date Received
- Jan 21, 1980
- 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
- 510(k)