Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010395077

FEI Number

3010395077

Entity Name

B'ORZE INC

City/State/Country

Boise, ID, US

Establishment Address

950 W Bannock, Suite 100, Boise, ID 83702, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

B'Orze Inc USA (Owner Number: 10046152)

Owner / Operator Contact Address

950 W Bannock Suite 1100, Boise, ID 83702, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252202

PMA Number

N/A

All Registered Proprietary Names

B`ORZE FETAL MONITOR WL 15000 MODEL NO BZ - WL - 015 - 01 B`ORZE INC DIGITAL VIDEO COLPOSCOPE HD INTTELLIO MODEL NO BZ-HD1-001

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2024-05-11
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2024-05-11
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2025-09-06

Official Correspondent

Rex Frazier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

B'Orze Inc USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

Similar Registrations

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1424263	Isomedix Operations, Inc.	Libertyville, IL, US
3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010395077. Last updated year: 2026. Please use registration number 3010395077 when referencing this establishment in official correspondence.