EVERON

Monitor, Breathing Frequency

EARLYSENSE LTD.

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

Pre-market Notification Details

• Device ID: K082465
• 510k Number: K082465
• Device Name: EVERON
• Classification: Monitor, Breathing Frequency
• Applicant: EARLYSENSE LTD. 12 TZVI STREET Ramat Gan, IL 52504
• Contact: Dalia Argaman
• Correspondent: Dalia Argaman; EARLYSENSE LTD. 12 TZVI STREET 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: 2008-08-27
• Decision Date: 2009-03-25
• Summary: summary