510(k) K844916
K844916 is an FDA 510(k) premarket notification submitted by Hoffrel Instruments, Inc. for the device "MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER". The FDA issued a decision of Substantially Equivalent on April 22, 1985. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Hoffrel Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1985
- Date Received
- December 18, 1984
- 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