F10

FDA 510(k) K110630 · Mediana Co., Ltd.

Substantially Equivalent

510(k) numberK110630

Submission

Device name
F10
Applicant
Mediana Co., Ltd.
Wonju-City, Gangwon-Do, KR
Received
March 3, 2011
Decision date
June 24, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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Questions and answers

When was F10 cleared by the FDA?

F10 (K110630) received a 510(k) decision of Substantially Equivalent on June 24, 2011, 113 days after the submission was received.

What is the product code of K110630?

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