Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K133859 |
Device Name |
WATCH-PAT200U (WP200U) |
Applicant |
ITAMAR MEDICAL LTD |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN KAHAN, ESQ |
Correspondent |
ITAMAR MEDICAL LTD |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN KAHAN, ESQ |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 12/19/2013 |
Decision Date | 05/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00881829
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|