Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K072201 |
Device Name |
COMPUMEDICS SOMTE PSG RECORDING SYSTEM |
Applicant |
COMPUMEDICS LIMITED |
30-40 FLOCKHART STREET |
ABBOTSFORD |
MELBOURNE, VICTORIA,
AU
3067
|
|
Applicant Contact |
GORDON FERGUSON |
Correspondent |
COMPUMEDICS LIMITED |
30-40 FLOCKHART STREET |
ABBOTSFORD |
MELBOURNE, VICTORIA,
AU
3067
|
|
Correspondent Contact |
GORDON FERGUSON |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 08/08/2007 |
Decision Date | 04/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|