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FDA 510(k)

MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR

K-Number: K894030 · 1990-01-22

ApplicantHealthdyne, Inc.
Decision Date1990-01-22
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K894030. 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 MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR?

MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Healthdyne, Inc.. The 510(k) number is K894030.

When did MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR receive FDA 510(k) clearance?

MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR received FDA 510(k) clearance on 1990-01-22, under 510(k) number K894030.

Who is the listed applicant for MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR?

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

What is the FDA product code for MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR?

The FDA product code for MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR is HFM.

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Other records listing Healthdyne, 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.

K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK922623NEBULIZER SYSTEM

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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.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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