Identifiers
- 510(k) Number
- K131379 FDA 510(k)
- FDA Product Code
- BZQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Earlysense device is a Monitor, Breathing Frequency, classified under medical specialty Anesthesiology. It is a substantially equivalent device cleared via the traditional 510(k) pathway.
It is manufactured by Earlysense, Ltd., located at 12 Tzvi St., Ramat-Gan, Israel, postal code 52504. The device has FDA 510(k) authorization under K131379, product code BZQ, and regulation number 868.2375.
Frequently asked questions
What is the EARLYSENSE device used for?
The EARLYSENSE device is a Monitor, Breathing Frequency intended for use in anesthesiology to monitor respiratory rate, as indicated by its classification under medical specialty Anesthesiology and product code BZQ.
How is the EARLYSENSE device supplied or authorized for use?
The EARLYSENSE device was cleared via the traditional 510(k) pathway under K131379, meaning it is substantially equivalent to a legally marketed predicate device and authorized for commercial distribution in the United States.
Who manufactures the EARLYSENSE device and where is it located?
The EARLYSENSE device is manufactured by Earlysense, Ltd., located at 12 Tzvi St., Ramat-Gan, Israel, postal code 52504, as stated in the device’s registration and manufacturer information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131379 | Class II | Active |
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Manufacturer
- Manufacturer
- Earlysense, Ltd.
Sources (1)
- FDA 510(k) K131379 24 fields · synced Sep 21, 2026