Babycare

FDA 510(k) K023082 · Bionet Company, Ltd.

Substantially Equivalent

510(k) numberK023082

Submission

Device name
Babycare
Applicant
Bionet Company, Ltd.
Alpharetta, GA, US
Received
September 17, 2002
Decision date
March 3, 2003
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEP – Monitor, Blood-Flow, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

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K910462Pocket Dop 3HEP · Traditional Imex Medical Systems, Inc.06/24/1991SE

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Questions and answers

When was Babycare cleared by the FDA?

Babycare (K023082) received a 510(k) decision of Substantially Equivalent on March 3, 2003, 167 days after the submission was received.

What is the product code of K023082?

The FDA product code is HEP – Monitor, Blood-Flow, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.