Continuous Wave Doppler

FDA 510(k) K760751 · Medsonics

Substantially Equivalent

510(k) numberK760751

Submission

Device name
Continuous Wave Doppler
Applicant
Medsonics
Mchenry, IL, US
Received
October 1, 1976
Decision date
October 13, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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K223843FloPatch FP120DPW · Traditional Flosonics Medical05/03/2023SE
K222242FloPatch FP120DPW · Traditional Flosonics Medical12/09/2022SE
K213974GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special Synovis Micro Companies Alliance, Inc.04/20/2022SE
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More from Remington Medical, Inc.

510(k)DeviceDecision
K770904Probe, Blood Flow Detector Plug-InKNG · Traditional 05/26/1977SE
K770332Amplifier, Photopulse, Model PA13JOM · Traditional 02/24/1977SE
K760728Continuous Wave Doppler UltrasoundKNG · Traditional 10/06/1976SE

Questions and answers

When was Continuous Wave Doppler cleared by the FDA?

Continuous Wave Doppler (K760751) received a 510(k) decision of Substantially Equivalent on October 13, 1976, 12 days after the submission was received.

What is the product code of K760751?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.