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Fetal Monitor, Models BT-300 and BT-200

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052190

by Bistos Co., Ltd.

Identifiers

510(k) Number
K052190 FDA 510(k)
FDA Product Code
HGM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.2740 FDA 510(k)
Regulation Number
884.2740 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a fetal monitor, specifically models BT-300 and BT-200, used for perinatal monitoring. It is classified as a System, Monitoring, Perinatal under FDA device classification and is substantially equivalent to a predicate device as determined through a traditional 510(k) clearance process.

The device is authorized under FDA 510(k) clearance K052190, received on August 11, 2005, and cleared on October 4, 2005. It is manufactured by Bistos Co., Ltd. and is intended for use in obstetrics and gynecology settings, as indicated by the advisory committee classification OB and medical specialty description Obstetrics/Gynecology.

Frequently asked questions

What is the fetal monitor BT-300 and BT-200 used for?

The fetal monitor models BT-300 and BT-200 are used for perinatal monitoring in obstetrics and gynecology settings, as indicated by the device's classification as a System, Monitoring, Perinatal and its medical specialty description of Obstetrics/Gynecology.

Who manufactures the BT-300 and BT-200 fetal monitors and where are they located?

The BT-300 and BT-200 fetal monitors are manufactured by Bistos Co., Ltd., located at 340 Shady Grove Rd., Flintville, TN 37335, United States, as specified in the device's address and contact information.

What regulatory pathway was used for the BT-300 and BT-200 fetal monitors?

The BT-300 and BT-200 fetal monitors received FDA 510(k) clearance through a traditional submission process, identified by K-number K052190, with a date received of August 11, 2005, and a decision date of October 4, 2005, confirming substantial equivalence to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fetal Monitor BT-300 - bistos.co.kr, Fetal Monitor - Bistos Bio Signal Total Solution We are researching ..., BISTOS BT-300 OPERATION MANUAL Pdf Download | ManualsLib, Bistos - BT-300 Fetal Monitor - gccpharma.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bistos Co., Ltd.

Sources (1)

  • FDA 510(k) K052190 24 fields · synced Oct 6, 2026