Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K092062 |
Device Name |
EVERON 1.0 |
Applicant |
EARLYSENSE LTD. |
TZVI 12 |
RAMAT-GAN,
IL
52504
|
|
Applicant Contact |
DALIA ARGAMAN |
Correspondent |
EARLYSENSE LTD. |
TZVI 12 |
RAMAT-GAN,
IL
52504
|
|
Correspondent Contact |
DALIA ARGAMAN |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/08/2009 |
Decision Date | 05/24/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|