Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K112822 |
Device Name |
SLEEPSTRIP II |
Applicant |
S.L.P LTD. |
62 ANILEVITZ STREET |
TEL-AVIV,
IL
67060
|
|
Applicant Contact |
NOAM HADAS |
Correspondent |
S.L.P LTD. |
62 ANILEVITZ STREET |
TEL-AVIV,
IL
67060
|
|
Correspondent Contact |
NOAM HADAS |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 09/28/2011 |
Decision Date | 12/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|