Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K112102 |
Device Name |
MICHELE SLEEP SCORING SYSTEMS |
Applicant |
YOUNES SLEEP TECHNOLOGIES |
435 ELLICE AVENUE |
WINNIPEG, MANITOBA,
CA
R3B 1Y6
|
|
Applicant Contact |
MAGDY YOUNES |
Correspondent |
YOUNES SLEEP TECHNOLOGIES |
435 ELLICE AVENUE |
WINNIPEG, MANITOBA,
CA
R3B 1Y6
|
|
Correspondent Contact |
MAGDY YOUNES |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/22/2011 |
Decision Date | 12/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|