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FDA 510(k)

DOPPLEX-PLB & PXB

K-Number: K810115 · 1981-07-16

ApplicantHuntleigh Technology, Inc.
Decision Date1981-07-16
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DOPPLEX-PLB & PXB is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Technology, Inc.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K810115. 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 DOPPLEX-PLB & PXB?

DOPPLEX-PLB & PXB is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Huntleigh Technology, Inc.. The 510(k) number is K810115.

When did DOPPLEX-PLB & PXB receive FDA 510(k) clearance?

DOPPLEX-PLB & PXB received FDA 510(k) clearance on 1981-07-16, under 510(k) number K810115.

Who is the listed applicant for DOPPLEX-PLB & PXB?

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

What is the FDA product code for DOPPLEX-PLB & PXB?

The FDA product code for DOPPLEX-PLB & PXB is KNG.

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Other records listing Huntleigh Technology, 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.

K992733AKRON ATP9 TRACTION MACHINEK964699RHEO DOPPLEX II (RD 2)K924516OP3/VP4K910188FLOWPLUS AC330 PUMP GARMENTSK900882MULTI DOPPLEX, MD-1K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140

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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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