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FDA 510(k)

FETAL HEART DETECTOR #'S D102 & D102R

K-Number: K800858 · 1980-05-14

ApplicantSonicaid, Inc.
Decision Date1980-05-14
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL HEART DETECTOR #'S D102 & D102R is the device name listed in this FDA 510(k) record. The listed applicant is Sonicaid, Inc.. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K800858. 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 FETAL HEART DETECTOR #'S D102 & D102R?

FETAL HEART DETECTOR #'S D102 & D102R is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Sonicaid, Inc.. The 510(k) number is K800858.

When did FETAL HEART DETECTOR #'S D102 & D102R receive FDA 510(k) clearance?

FETAL HEART DETECTOR #'S D102 & D102R received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800858.

Who is the listed applicant for FETAL HEART DETECTOR #'S D102 & D102R?

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

What is the FDA product code for FETAL HEART DETECTOR #'S D102 & D102R?

The FDA product code for FETAL HEART DETECTOR #'S D102 & D102R is KNG.

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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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