Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K083620 |
Device Name |
SOMNOLYZER 24X7 |
Applicant |
THE SIESTA GROUP NORTH AMERICA |
990 WASHINGTON STREET |
SUITE 204 |
DEDHAM,
MA
02026
|
|
Applicant Contact |
ZVI LADIN |
Correspondent |
THE SIESTA GROUP NORTH AMERICA |
990 WASHINGTON STREET |
SUITE 204 |
DEDHAM,
MA
02026
|
|
Correspondent Contact |
ZVI LADIN |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 12/08/2008 |
Decision Date | 03/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|