FDA 510(k)

BT-350

K-Number: K103545 · 2011-05-13

Decision Date2011-05-13

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

BT-350 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 2011-05-13 under 510(k) number K103545. 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 BT-350?

BT-350 is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K103545.

When did BT-350 receive FDA 510(k) clearance?

BT-350 received FDA 510(k) clearance on 2011-05-13, under 510(k) number K103545.

Who is the listed applicant for BT-350?

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 BT-350?

The FDA product code for BT-350 is HGM.

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.