Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026751377

FEI Number

3026751377

Entity Name

Xandar Kardian Korea Inc.

City/State/Country

Seoul, KR

Establishment Address

2F, 27, Gyeonghuigung-gil, Jongno-gu, Seoul 03176, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xandar Kardian Inc. (Owner Number: 10087145)

Owner / Operator Contact Address

2F, 27, Gyeonghuigung-gil, Jongno-gu, Seoul, KR-11 03176, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202464

PMA Number

N/A

All Registered Proprietary Names

XK300 XK300-E

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-01-17
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-01-17

Official Correspondent

Glen Choi

US Agent Details

Tyler Ting Business: Rook Quality Systems Email: tyler.ting@rookqs.com Phone: (970) 4041555

Related Public Records

Same Entity

Xandar Kardian Inc.

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
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009499478	EDAN Diagnostics, Inc.	San Diego, CA, US
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3017760831	Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.	Kulim Kedah, MY
3007305624	GUANGDONG BIOLIGHT MEDITECH CO., LTD	Zhuhai Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026751377. Last updated year: 2026. Please use registration number 3026751377 when referencing this establishment in official correspondence.