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FDA 510(k)

TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

K-Number: K010920 · 2001-06-22

ApplicantMedical Cables, Inc.
Decision Date2001-06-22
Product CodeHEL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Medical Cables, Inc.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K010920. The device is classified under product code HEL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING?

TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Medical Cables, Inc.. The 510(k) number is K010920.

When did TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING receive FDA 510(k) clearance?

TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING received FDA 510(k) clearance on 2001-06-22, under 510(k) number K010920.

Who is the listed applicant for TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING?

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

What is the FDA product code for TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING?

The FDA product code for TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING is HEL.

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 Medical Cables, 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.

K002781MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORSK973970SPO2 FINGER PROBES

Related Devices (Code: HEL)

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.

K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCard Guard Scientific Survival , Ltd.K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006Alexander Mfg. Co.K930714SONICAID MODEL TEAM FECG IUPOxford Instruments, Plc.K933816SONICAID MODEL P110 FETAL HEAR DETECTOROxford Instruments, Plc.K780035MINIVISORMetrix Teknika, 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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