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FDA 510(k)

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

K-Number: K992811 · 2000-01-18

ApplicantEpic Medical Equipment Services, Inc.
Decision Date2000-01-18
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Equipment Services, Inc.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K992811. 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 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING?

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Epic Medical Equipment Services, Inc.. The 510(k) number is K992811.

When did TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING receive FDA 510(k) clearance?

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING received FDA 510(k) clearance on 2000-01-18, under 510(k) number K992811.

Who is the listed applicant for TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING?

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

What is the FDA product code for TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING?

The FDA product code for TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING is HFM.

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Other records listing Epic Medical Equipment Services, 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.

K012333FLEXI-SITE SP02 EAR SENSORK002848SPO2 WRAP SENSORK010718FLEXI-SITE SP02 EAR SENSORK002223EPIC SPO2 FINGER SENSOR, MODEL E412-20K000831STAT-SHELL DISPOSABLE SP02 SENSORK992211SPO2 WRAP SENSOR

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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.K013477TOCO LITE, MODEL TD-01Ventrex, Inc.K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.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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