Multi-Dop L

FDA 510(k) K930458 · Dantec Medical, Inc.

Substantially Equivalent

510(k) numberK930458

Submission

Device name
Multi-Dop L
Applicant
Dantec Medical, Inc.
Washington, DC, US
Received
January 28, 1993
Decision date
February 3, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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Questions and answers

When was Multi-Dop L cleared by the FDA?

Multi-Dop L (K930458) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 736 days after the submission was received.

What is the product code of K930458?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.