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FDA 510(k)

F10

K-Number: K110630 · 2011-06-24

ApplicantMediana Co., Ltd.
Decision Date2011-06-24
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

F10 is the device name listed in this FDA 510(k) record. The listed applicant is Mediana Co., Ltd.. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K110630. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F10?

F10 is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Mediana Co., Ltd.. The 510(k) number is K110630.

When did F10 receive FDA 510(k) clearance?

F10 received FDA 510(k) clearance on 2011-06-24, under 510(k) number K110630.

Who is the listed applicant for F10?

The FDA 510(k) record lists Mediana Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F10?

The FDA product code for F10 is KNG.

Other records listing Mediana Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200434V20, V20a, AVSM3 SNFK170497V10K160358DT-100K152659V10K112190PATIENT MONITORK110612FM20

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Related Devices (Code: KNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic FactoryK242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,LtdK220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,LtdK211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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