Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CONTEC POCKET FETAL DOPPLER

K-Number: K082480 · 2009-02-25

ApplicantContec Medical System Co., Ltd.
Decision Date2009-02-25
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONTEC POCKET FETAL DOPPLER is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2009-02-25 under 510(k) number K082480. 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 CONTEC POCKET FETAL DOPPLER?

CONTEC POCKET FETAL DOPPLER is a medical device that received FDA 510(k) clearance on 2009-02-25. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K082480.

When did CONTEC POCKET FETAL DOPPLER receive FDA 510(k) clearance?

CONTEC POCKET FETAL DOPPLER received FDA 510(k) clearance on 2009-02-25, under 510(k) number K082480.

Who is the listed applicant for CONTEC POCKET FETAL DOPPLER?

The FDA 510(k) record lists Contec Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTEC POCKET FETAL DOPPLER?

The FDA product code for CONTEC POCKET FETAL DOPPLER is KNG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Contec Medical System Co., Ltd. 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.

K180837CONTEC Oxygen ConcentratorK101273DYNAMIC ECG SYSTEM MODEL TLC5000K110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,K101692PATIENT MONITORK110774ELECTRONIC SPHYGMOMANOMETERK101127PATIENT MONITOR, MODEL PM50

View all 11 devices →

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.

↑