Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K081982 |
Device Name |
WATCH-PAT 200S-2 (WP200S-2) |
Applicant |
ITAMAR MEDICAL |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
ITAMAR MEDICAL |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/11/2008 |
Decision Date | 08/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|