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FDA 510(k)

BIOSYS FETAL MONITOR, MODEL IFM-500

K-Number: K994008 · 2000-09-29

ApplicantBiosys Co. , Ltd.
Decision Date2000-09-29
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIOSYS FETAL MONITOR, MODEL IFM-500 is the device name listed in this FDA 510(k) record. The listed applicant is Biosys Co. , Ltd.. It received FDA 510(k) clearance on 2000-09-29 under 510(k) number K994008. 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 BIOSYS FETAL MONITOR, MODEL IFM-500?

BIOSYS FETAL MONITOR, MODEL IFM-500 is a medical device that received FDA 510(k) clearance on 2000-09-29. The listed applicant is Biosys Co. , Ltd.. The 510(k) number is K994008.

When did BIOSYS FETAL MONITOR, MODEL IFM-500 receive FDA 510(k) clearance?

BIOSYS FETAL MONITOR, MODEL IFM-500 received FDA 510(k) clearance on 2000-09-29, under 510(k) number K994008.

Who is the listed applicant for BIOSYS FETAL MONITOR, MODEL IFM-500?

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

What is the FDA product code for BIOSYS FETAL MONITOR, MODEL IFM-500?

The FDA product code for BIOSYS FETAL MONITOR, MODEL IFM-500 is HGM.

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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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