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FDA 510(k)

TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT

K-Number: K852704 · 1985-11-26

ApplicantClincal Instruments Corp.
Decision Date1985-11-26
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT is the device name listed in this FDA 510(k) record. The listed applicant is Clincal Instruments Corp.. It received FDA 510(k) clearance on 1985-11-26 under 510(k) number K852704. 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 TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT?

TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT is a medical device that received FDA 510(k) clearance on 1985-11-26. The listed applicant is Clincal Instruments Corp.. The 510(k) number is K852704.

When did TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT receive FDA 510(k) clearance?

TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT received FDA 510(k) clearance on 1985-11-26, under 510(k) number K852704.

Who is the listed applicant for TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT?

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

What is the FDA product code for TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT?

The FDA product code for TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT is HGM.

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Other records listing Clincal Instruments 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.

K902327EMBOLECTOMY CATHETERK860743CAROTID BYPASS SHUNT WITH SAMPLING ARMK860742CAROTID BYPASS SHUNTK844918OCCLUSION & OCCLUSION-IRRIGATIONK821220MULTILUMEN INTRAVENOUS INFUSION CATHETERK790034INTRODUCERS

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Related Devices (Code: HGM)

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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

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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