Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028169073

FEI Number

3028169073

Entity Name

FACEHEART CORP.

City/State/Country

Taiwan Hsinchu (City), TW

Establishment Address

Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75,, Bo'ai St., East Dist.,, Taiwan Hsinchu (City) 300, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FaceHeart Corporation (Owner Number: 10088632)

Owner / Operator Contact Address

Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75,, Bo'ai St., East Dist.,, Hsinchu City, TW-HSZ 300, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243966

PMA Number

N/A

All Registered Proprietary Names

Software, non contact, optical camera-based measurement of respiratory rate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-06-01

Official Correspondent

Meng Liang Chung

US Agent Details

Jerry Chang Business: President Email: jerry.chang@faceheart.com Phone: (650) 9963693

Related Public Records

Same Entity

FaceHeart Corporation

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
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

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3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028169073. Last updated year: 2026. Please use registration number 3028169073 when referencing this establishment in official correspondence.