FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EARLYSENSE CENTRAL DISPLAY SYSTEM
K Number: K121885
·
Decision Sep 10, 2012
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
12
Review Days
74
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Basic Information
- Device Name
- EARLYSENSE CENTRAL DISPLAY SYSTEM
- K Number
- K121885
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Earlysense, Ltd.
- Date Received
- June 28, 2012
- Decision Date
- September 10, 2012
- Product Code
- MSX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K092062 | EVERON 1.0 | May 24, 2010 | Substantially Equivalent |
| K082465 | EVERON | Mar 25, 2009 | Substantially Equivalent |