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FDA 510(k)

AIR-CUSHION TOCOTONOMETER

K-Number: K860933 · 1986-07-09

ApplicantInternational Biomedics, Inc.
Decision Date1986-07-09
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AIR-CUSHION TOCOTONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedics, Inc.. It received FDA 510(k) clearance on 1986-07-09 under 510(k) number K860933. 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 AIR-CUSHION TOCOTONOMETER?

AIR-CUSHION TOCOTONOMETER is a medical device that received FDA 510(k) clearance on 1986-07-09. The listed applicant is International Biomedics, Inc.. The 510(k) number is K860933.

When did AIR-CUSHION TOCOTONOMETER receive FDA 510(k) clearance?

AIR-CUSHION TOCOTONOMETER received FDA 510(k) clearance on 1986-07-09, under 510(k) number K860933.

Who is the listed applicant for AIR-CUSHION TOCOTONOMETER?

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

What is the FDA product code for AIR-CUSHION TOCOTONOMETER?

The FDA product code for AIR-CUSHION TOCOTONOMETER is HFM.

Related Clinical Trials

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Other records listing International Biomedics, 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.

K031096MODIFICATION TO TRANSPORT INCUBATOR 185K862072FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01K860295FETASCAN 1500K852439FETA SCAN 1000 OBSTETRICAL IMAGER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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