Vingmed DS100 Doppler Flowmeter

FDA 510(k) K843933 · Vingmed, Inc.

Substantially Equivalent

510(k) numberK843933

Submission

Device name
Vingmed DS100 Doppler Flowmeter
Applicant
Vingmed, Inc.
Ramsey, NJ, US
Received
October 5, 1984
Decision date
February 13, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAF – Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Specialty
Radiology

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Questions and answers

When was Vingmed DS100 Doppler Flowmeter cleared by the FDA?

Vingmed DS100 Doppler Flowmeter (K843933) received a 510(k) decision of Substantially Equivalent on February 13, 1985, 131 days after the submission was received.

What is the product code of K843933?

The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.