Probe, Blood Flow Detector Plug-In

FDA 510(k) K770904 · Medsonics

Substantially Equivalent

510(k) numberK770904

Submission

Device name
Probe, Blood Flow Detector Plug-In
Applicant
Medsonics
Mchenry, IL, US
Received
May 16, 1977
Decision date
May 26, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNG – Monitor, Ultrasonic, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

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More from Shenzzhen Luckcome Technology Inc., Ltd.

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K770332Amplifier, Photopulse, Model PA13JOM · Traditional 02/24/1977SE
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Questions and answers

When was Probe, Blood Flow Detector Plug-In cleared by the FDA?

Probe, Blood Flow Detector Plug-In (K770904) received a 510(k) decision of Substantially Equivalent on May 26, 1977, 10 days after the submission was received.

What is the product code of K770904?

The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.