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FDA 510(k)

TOITU DOPPLER FETUS DETECTOR, FD-400D

K-Number: K890139 · 1989-03-29

ApplicantToitu of America, Inc.
Decision Date1989-03-29
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TOITU DOPPLER FETUS DETECTOR, FD-400D is the device name listed in this FDA 510(k) record. The listed applicant is Toitu of America, Inc.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K890139. 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 TOITU DOPPLER FETUS DETECTOR, FD-400D?

TOITU DOPPLER FETUS DETECTOR, FD-400D is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Toitu of America, Inc.. The 510(k) number is K890139.

When did TOITU DOPPLER FETUS DETECTOR, FD-400D receive FDA 510(k) clearance?

TOITU DOPPLER FETUS DETECTOR, FD-400D received FDA 510(k) clearance on 1989-03-29, under 510(k) number K890139.

Who is the listed applicant for TOITU DOPPLER FETUS DETECTOR, FD-400D?

The FDA 510(k) record lists Toitu of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOITU DOPPLER FETUS DETECTOR, FD-400D?

The FDA product code for TOITU DOPPLER FETUS DETECTOR, FD-400D is KNG.

Related Clinical Trials

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Other records listing Toitu of America, Inc. 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.

K894036TOITU FETAL ACTOCARDIOGRAPH, MT-332

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

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

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