Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K964494 |
Device Name |
SLEEPWIZARD |
Applicant |
NELLCOR PURITAN BENNETT, INC. |
10200 VALLEY VIEW RD. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
CHRIS HADLAND |
Correspondent |
NELLCOR PURITAN BENNETT, INC. |
10200 VALLEY VIEW RD. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
CHRIS HADLAND |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 11/08/1996 |
Decision Date | 02/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|