Model 518 & 519 Ultrasonoscope W/Doppler
FDA 510(k) K844916 · Hoffrel Instruments, Inc.
510(k) numberK844916
Submission
- Device name
- Model 518 & 519 Ultrasonoscope W/Doppler
- Applicant
- Hoffrel Instruments, Inc.
South Norwalk, CT, US - Received
- December 18, 1984
- Decision date
- April 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Model 518 & 519 Ultrasonoscope W/Doppler cleared by the FDA?
Model 518 & 519 Ultrasonoscope W/Doppler (K844916) received a 510(k) decision of Substantially Equivalent on April 22, 1985, 125 days after the submission was received.
What is the product code of K844916?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.