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FDA 510(k)

POCKET SIZE FETAL HEART DETECTOR

K-Number: K920056 · 1992-12-11

ApplicantMedical Accessories, Inc.
Decision Date1992-12-11
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

POCKET SIZE FETAL HEART DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Accessories, Inc.. It received FDA 510(k) clearance on 1992-12-11 under 510(k) number K920056. 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 POCKET SIZE FETAL HEART DETECTOR?

POCKET SIZE FETAL HEART DETECTOR is a medical device that received FDA 510(k) clearance on 1992-12-11. The listed applicant is Medical Accessories, Inc.. The 510(k) number is K920056.

When did POCKET SIZE FETAL HEART DETECTOR receive FDA 510(k) clearance?

POCKET SIZE FETAL HEART DETECTOR received FDA 510(k) clearance on 1992-12-11, under 510(k) number K920056.

Who is the listed applicant for POCKET SIZE FETAL HEART DETECTOR?

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

What is the FDA product code for POCKET SIZE FETAL HEART DETECTOR?

The FDA product code for POCKET SIZE FETAL HEART DETECTOR is KNG.

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Other records listing Medical Accessories, Inc. as applicant

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K901152REDYPLATE DISPOSABLE LEG PLATEK872057FETAL SCALP ELECTRODE

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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