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FDA 510(k)

TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

K-Number: K043075 · 2005-08-18

ApplicantTenacore Holdings, Inc.
Decision Date2005-08-18
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Tenacore Holdings, Inc.. It received FDA 510(k) clearance on 2005-08-18 under 510(k) number K043075. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING?

TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING is a medical device that received FDA 510(k) clearance on 2005-08-18. The listed applicant is Tenacore Holdings, Inc.. The 510(k) number is K043075.

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

TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING received FDA 510(k) clearance on 2005-08-18, under 510(k) number K043075.

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

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

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

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

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 Tenacore Holdings, 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.

K081335TENACORE OXYGEN BLENDER, MODEL TB-2000K053420TENACORE SP02 SENSORSK012041THE HAMMER MODEL H100

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, 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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