Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1062836

FEI Number

3000718682

Entity Name

DIGICARE BIOMEDICAL TECHNOLOGY, INC.

City/State/Country

BOYNTON BEACH, FL, US

Establishment Address

107 COMMERCE RD., BOYNTON BEACH, FL 33426, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIGICARE BIOMEDICAL TECHNOLOGY, INC. (Owner Number: 9029705)

Owner / Operator Contact Address

107 COMMERCE RD., --, BOYNTON BEACH, FL 33426, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183687

PMA Number

N/A

All Registered Proprietary Names

LifeWindow LW8 Lite Multi-Parameter Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-09-26
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2019-09-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-09-26
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-09-26
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2019-09-26
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-09-26
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-09-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-09-26

Official Correspondent

ADRIANA MIRANDA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIGICARE BIOMEDICAL TECHNOLOGY, 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number	Establishment Name	Location
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH
3010222749	SEERS CO., LTD.	Pyeongtaek Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1062836. Last updated year: 2026. Please use registration number 1062836 when referencing this establishment in official correspondence.