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FDA 510(k)

FETAL MONITOR MODEL: BT-200T

K-Number: K100885 · 2010-06-07

ApplicantBistos Co., Ltd.
Decision Date2010-06-07
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITOR MODEL: BT-200T is the device name listed in this FDA 510(k) record. The listed applicant is Bistos Co., Ltd.. It received FDA 510(k) clearance on 2010-06-07 under 510(k) number K100885. 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 FETAL MONITOR MODEL: BT-200T?

FETAL MONITOR MODEL: BT-200T is a medical device that received FDA 510(k) clearance on 2010-06-07. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K100885.

When did FETAL MONITOR MODEL: BT-200T receive FDA 510(k) clearance?

FETAL MONITOR MODEL: BT-200T received FDA 510(k) clearance on 2010-06-07, under 510(k) number K100885.

Who is the listed applicant for FETAL MONITOR MODEL: BT-200T?

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

What is the FDA product code for FETAL MONITOR MODEL: BT-200T?

The FDA product code for FETAL MONITOR MODEL: BT-200T is HGM.

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Other records listing Bistos Co., Ltd. as applicant

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Related Devices (Code: HGM)

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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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