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FDA 510(k)

FETAL MONITOR, MODELS BT-300 AND BT-200

K-Number: K052190 · 2005-10-04

ApplicantBistos Co., Ltd.
Decision Date2005-10-04
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITOR, MODELS BT-300 AND BT-200 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 2005-10-04 under 510(k) number K052190. 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, MODELS BT-300 AND BT-200?

FETAL MONITOR, MODELS BT-300 AND BT-200 is a medical device that received FDA 510(k) clearance on 2005-10-04. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K052190.

When did FETAL MONITOR, MODELS BT-300 AND BT-200 receive FDA 510(k) clearance?

FETAL MONITOR, MODELS BT-300 AND BT-200 received FDA 510(k) clearance on 2005-10-04, under 510(k) number K052190.

Who is the listed applicant for FETAL MONITOR, MODELS BT-300 AND BT-200?

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, MODELS BT-300 AND BT-200?

The FDA product code for FETAL MONITOR, MODELS BT-300 AND BT-200 is HGM.

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Other records listing Bistos Co., Ltd. as applicant

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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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