BIOBEAT TECHNOLOGIES LTD

FDA Device Registration & Listing · Petakh Tikva Central, IL · Registration 3015455735

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015455735
FEI Number
3015455735
Entity Name
BIOBEAT TECHNOLOGIES LTD
City/State/Country
Petakh Tikva Central, IL
Establishment Address
10, Moshe Dayan, Petakh Tikva Central 4951810, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Biobeat Technologies LTD (Owner Number: 10082659)
Owner / Operator Contact Address
10 Moshe Dayan Street, Petach Tikva, IL-M 4951810, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241066
PMA Number
N/A

All Registered Proprietary Names

Biobeat Platform 2 BB613WP BB613 BB-613-BPM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-10-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-10-11
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2023-10-11
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-10-11
DQA Oximeter Cardiovascular Class 2 870.2700 2023-10-11
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2023-10-11
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2022-11-29
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-11-29
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-29
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-11-29
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-29
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-29
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2025-02-02
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-02-02
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2025-02-02

Official Correspondent

Johanan May

US Agent Details

Naphtali Deutsch Business: A. Stein Regulatory Affairs Email: Ahava@asteinrac.com Phone: (888) 4433867

Related Public Records

Same Entity

Biobeat Technologies LTD
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
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015455735. Last updated year: 2026. Please use registration number 3015455735 when referencing this establishment in official correspondence.
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