EARLYSENSE

Monitor, Breathing Frequency

EARLYSENSE LTD.

The following data is part of a premarket notification filed by Earlysense Ltd. with the FDA for Earlysense.

Pre-market Notification Details

• Device ID: K131379
• 510k Number: K131379
• Device Name: EARLYSENSE
• Classification: Monitor, Breathing Frequency
• Applicant: EARLYSENSE LTD. 12 TZVI ST Ramat-gan, IL 52504
• Contact: Dalia Argaman
• Correspondent: Dalia Argaman; EARLYSENSE LTD. 12 TZVI ST Ramat-gan, IL 52504
• Product Code: BZQ
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-14
• Decision Date: 2013-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290016169089	K131379	000
17290016169017	K131379	000