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FDA 510(k)

TOCO LITE, MODEL TD-01

K-Number: K013477 · 2002-01-17

ApplicantVentrex, Inc.
Decision Date2002-01-17
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TOCO LITE, MODEL TD-01 is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex, Inc.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K013477. The device is classified under product code HFM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOCO LITE, MODEL TD-01?

TOCO LITE, MODEL TD-01 is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Ventrex, Inc.. The 510(k) number is K013477.

When did TOCO LITE, MODEL TD-01 receive FDA 510(k) clearance?

TOCO LITE, MODEL TD-01 received FDA 510(k) clearance on 2002-01-17, under 510(k) number K013477.

Who is the listed applicant for TOCO LITE, MODEL TD-01?

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

What is the FDA product code for TOCO LITE, MODEL TD-01?

The FDA product code for TOCO LITE, MODEL TD-01 is HFM.

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 Ventrex, 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.

K061044FEATHERLITE AQUA TOCODYNAMOMETERK964821COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67K925044VENTREX ALLERGEN DISCK924119VENTREX ALLERGEN DISC

Related Devices (Code: HFM)

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.

K061044FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, Inc.K952579TOCO TRANSDUCERScientific Device Manufacturer, LLC

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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