DRG Reaction Chamber/Safety Tip

FDA 510(k) K012003 · Doctor'S Research Group, Inc.

Substantially Equivalent

510(k) numberK012003

Submission

Device name
DRG Reaction Chamber/Safety Tip
Applicant
Doctor'S Research Group, Inc.
Wolcott, CT, US
Received
June 27, 2001
Decision date
February 12, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEI – Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

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Questions and answers

When was DRG Reaction Chamber/Safety Tip cleared by the FDA?

DRG Reaction Chamber/Safety Tip (K012003) received a 510(k) decision of Substantially Equivalent on February 12, 2002, 230 days after the submission was received.

What is the product code of K012003?

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