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FDA 510(k)

FC 1400 FETAL MONITOR

K-Number: K043598 · 2005-12-16

ApplicantBionet Co., Ltd.
Decision Date2005-12-16
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FC 1400 FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Co., Ltd.. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K043598. 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 FC 1400 FETAL MONITOR?

FC 1400 FETAL MONITOR is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Bionet Co., Ltd.. The 510(k) number is K043598.

When did FC 1400 FETAL MONITOR receive FDA 510(k) clearance?

FC 1400 FETAL MONITOR received FDA 510(k) clearance on 2005-12-16, under 510(k) number K043598.

Who is the listed applicant for FC 1400 FETAL MONITOR?

The FDA 510(k) record lists Bionet Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FC 1400 FETAL MONITOR?

The FDA product code for FC 1400 FETAL MONITOR is HGM.

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Other records listing Bionet Co., Ltd. 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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