Earlysense (Everon) System
FDA 510(k) K120465 · Earlysense, Ltd.
510(k) numberK120465
Submission
- Device name
- Earlysense (Everon) System
- Applicant
- Earlysense, Ltd.
Ramat-Gan, IL - Received
- February 15, 2012
- Decision date
- June 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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More from Linshom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171836 | EarlySense Bed Sensing UnitBZQ · Traditional | 01/04/2018SE |
| K152911 | EarlySense Insight SytemBZQ · Traditional | 05/06/2016SE |
| K151006 | EarlySense Central Display Station (CDS)MSX · Traditional | 08/31/2015SE |
| K133661 | Chair Sensing Unit for Earlysense SystemBZQ · Traditional | 06/13/2014SE |
| K131379 | EarlysenseBZQ · Traditional | 12/18/2013SE |
| K121885 | Earlysense Central Display SystemMSX · Special | 09/10/2012SE |
| K110521 | Everon Central Display Station (CDS)MSX · Special | 04/19/2011SE |
| K100376 | Everon Central Display Station - CDS, Model Version 1.0.0MSX · Traditional | 08/06/2010SE |
| K092062 | Everon 1.0BZQ · Traditional | 05/24/2010SE |
| K082465 | EveronBZQ · Traditional | 03/25/2009SE |
Questions and answers
When was Earlysense (Everon) System cleared by the FDA?
Earlysense (Everon) System (K120465) received a 510(k) decision of Substantially Equivalent on June 8, 2012, 114 days after the submission was received.
What is the product code of K120465?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.