Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K950273 |
Device Name |
SLEEP TEST(TM) |
Applicant |
CNS, INC. |
1250 PARK RD. |
CHANHASSEN,
MN
55317
|
|
Applicant Contact |
M.W. ANDY ANDERSON |
Correspondent |
CNS, INC. |
1250 PARK RD. |
CHANHASSEN,
MN
55317
|
|
Correspondent Contact |
M.W. ANDY ANDERSON |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 01/23/1995 |
Decision Date | 09/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|