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FDA 510(k)

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565

K-Number: K994353 · 2000-03-22

ApplicantPrecision Dynamics Corp.
Decision Date2000-03-22
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dynamics Corp.. It received FDA 510(k) clearance on 2000-03-22 under 510(k) number K994353. 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 SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565?

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 is a medical device that received FDA 510(k) clearance on 2000-03-22. The listed applicant is Precision Dynamics Corp.. The 510(k) number is K994353.

When did SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 receive FDA 510(k) clearance?

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 received FDA 510(k) clearance on 2000-03-22, under 510(k) number K994353.

Who is the listed applicant for SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565?

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

What is the FDA product code for SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565?

The FDA product code for SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 is HFM.

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Other records listing Precision Dynamics 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.

K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEK994263SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540K990737'ECURLINE UMBILICAL CORD CLAMP #3500K884357PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEMK882580MECHANICAL CHANGE IN IN-VITRO MICRO DEVICEK874665SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY

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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.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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