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FDA 510(k)

KONTRON FAX FETAL MONITOR

K-Number: K842422 · 1985-09-20

ApplicantKontron Instruments, Inc.
Decision Date1985-09-20
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KONTRON FAX FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K842422. 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 KONTRON FAX FETAL MONITOR?

KONTRON FAX FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K842422.

When did KONTRON FAX FETAL MONITOR receive FDA 510(k) clearance?

KONTRON FAX FETAL MONITOR received FDA 510(k) clearance on 1985-09-20, under 510(k) number K842422.

Who is the listed applicant for KONTRON FAX FETAL MONITOR?

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

What is the FDA product code for KONTRON FAX FETAL MONITOR?

The FDA product code for KONTRON FAX FETAL MONITOR is HGM.

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Other records listing Kontron Instruments, Inc. as applicant

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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

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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