Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K934599 |
Device Name |
SANDMAN |
Applicant |
MELVILLE SOFTWARE LTD. |
350 SPARKS ST. |
SUITE 1007 |
OTTAWA, ONTARIO,
CA
K1R 7S8
|
|
Applicant Contact |
DAVID N BAKER |
Correspondent |
MELVILLE SOFTWARE LTD. |
350 SPARKS ST. |
SUITE 1007 |
OTTAWA, ONTARIO,
CA
K1R 7S8
|
|
Correspondent Contact |
DAVID N BAKER |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 09/24/1993 |
Decision Date | 01/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|