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FDA 510(k)

FETAL PULSE DETECTORS, F50/F60

K-Number: K812868 · 1981-11-25

ApplicantSouth Carolina Medical, Inc.
Decision Date1981-11-25
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL PULSE DETECTORS, F50/F60 is the device name listed in this FDA 510(k) record. The listed applicant is South Carolina Medical, Inc.. It received FDA 510(k) clearance on 1981-11-25 under 510(k) number K812868. 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 PULSE DETECTORS, F50/F60?

FETAL PULSE DETECTORS, F50/F60 is a medical device that received FDA 510(k) clearance on 1981-11-25. The listed applicant is South Carolina Medical, Inc.. The 510(k) number is K812868.

When did FETAL PULSE DETECTORS, F50/F60 receive FDA 510(k) clearance?

FETAL PULSE DETECTORS, F50/F60 received FDA 510(k) clearance on 1981-11-25, under 510(k) number K812868.

Who is the listed applicant for FETAL PULSE DETECTORS, F50/F60?

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

What is the FDA product code for FETAL PULSE DETECTORS, F50/F60?

The FDA product code for FETAL PULSE DETECTORS, F50/F60 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

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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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