FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EVERON 1.0
K Number: K092062
·
Decision May 24, 2010
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
12
Review Days
320
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EVERON 1.0
- K Number
- K092062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Earlysense, Ltd.
- Date Received
- July 8, 2009
- Decision Date
- May 24, 2010
- Product Code
- BZQ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZQ), ordered by most recent decision date.
Respiration Rate algorithm
FDA 510(k)
FDA Class 2
·Anesthesiology
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Respiree Cardio- Respiratory Monitor System
FDA 510(k)
FDA Class 2
·Anesthesiology
RTMsense Respiratory Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
FDA 510(k)
FDA Class 2
·Anesthesiology
Philips VSC-MEDlib
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Earlysense, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K171836 | EarlySense Bed Sensing Unit | Jan 4, 2018 | Substantially Equivalent |
| K152911 | EarlySense Insight Sytem | May 6, 2016 | Substantially Equivalent |
| K151006 | EarlySense Central Display Station (CDS) | Aug 31, 2015 | Substantially Equivalent |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | Jun 13, 2014 | Substantially Equivalent |
| K131379 | EARLYSENSE | Dec 18, 2013 | Substantially Equivalent |
| K121885 | EARLYSENSE CENTRAL DISPLAY SYSTEM | Sep 10, 2012 | Substantially Equivalent |
| K120465 | EARLYSENSE (EVERON) SYSTEM | Jun 8, 2012 | Substantially Equivalent |
| K110521 | EVERON CENTRAL DISPLAY STATION (CDS) | Apr 19, 2011 | Substantially Equivalent |
| K100376 | EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 | Aug 6, 2010 | Substantially Equivalent |
| K082465 | EVERON | Mar 25, 2009 | Substantially Equivalent |