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FDA 510(k)

TERM GUARD 5000 UTERINE ACTIVITY

K-Number: K843011 · 1984-11-01

ApplicantTokos Medical Corp.
Decision Date1984-11-01
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TERM GUARD 5000 UTERINE ACTIVITY is the device name listed in this FDA 510(k) record. The listed applicant is Tokos Medical Corp.. It received FDA 510(k) clearance on 1984-11-01 under 510(k) number K843011. 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 TERM GUARD 5000 UTERINE ACTIVITY?

TERM GUARD 5000 UTERINE ACTIVITY is a medical device that received FDA 510(k) clearance on 1984-11-01. The listed applicant is Tokos Medical Corp.. The 510(k) number is K843011.

When did TERM GUARD 5000 UTERINE ACTIVITY receive FDA 510(k) clearance?

TERM GUARD 5000 UTERINE ACTIVITY received FDA 510(k) clearance on 1984-11-01, under 510(k) number K843011.

Who is the listed applicant for TERM GUARD 5000 UTERINE ACTIVITY?

The FDA 510(k) record lists Tokos Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERM GUARD 5000 UTERINE ACTIVITY?

The FDA product code for TERM GUARD 5000 UTERINE ACTIVITY 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.

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Other records listing Tokos Medical Corp. 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.

K893770TERM GUARD II DEVICE

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.K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, Inc.

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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