Data / Medical devices / Israel / Biobeat Technologies Ltd
Biobeat Technologies Ltd: FDA-registered device maker in Petakh Tikva Central, Israel, 5 510(k) clearances
Biobeat Technologies Ltd is registered with the FDA (registration 3015455735) in Petakh Tikva Central, Israel. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015455735
- Address
- 10, Moshe Dayan, Petakh Tikva Central, Israel, 4951810
- Owner or operator
- Biobeat Technologies LTD (10082659)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- September 2, 2021
- Registered through
- 2026
- Brand names listed
- BB-613 WP, BB-613-BPM, BB613, BB613WP, Biobeat Platform 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2025 | K241066 | BB-613-BPM | DXN | Substantially Equivalent | Biobeat Technologies , Ltd. | accessdata.fda.gov |
| December 30, 2022 | K222010 | Biobeat Platform-2 and BB-613WP Patch | DQA | Substantially Equivalent | Biobeat Technologies , Ltd. | accessdata.fda.gov |
| March 25, 2022 | K212153 | Biobeat Platform, BB-613WP Patch | DQA | Substantially Equivalent | Biobeat Technologies , Ltd. | accessdata.fda.gov |
| August 22, 2019 | K190792 | BB-613WP | DQA | Substantially Equivalent | Biobeat Technologies , Ltd. | accessdata.fda.gov |
| September 21, 2018 | K181006 | BB-613 Watch Oximeter | DQA | Substantially Equivalent | Bio-Beat Technologies , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Pre-Programmed, Single-Function
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Oximeter
- All makers of Monitor, Breathing Frequency
- All makers of Continuous Measurement Thermometer
Updated January 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.