Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K173181 |
Device Name |
ExSpiron 1Xi |
Applicant |
Respiratory Motion Inc. |
411 Waverly Oaks Road, Building 1, Suite 150 |
Waltham,
MA
02452
|
|
Applicant Contact |
Susan Hamann |
Correspondent |
Respiratory Motion Inc. |
411 Waverly Oaks Road, Building 1, Suite 150 |
Waltham,
MA
02452
|
|
Correspondent Contact |
Susan Hamann |
Regulation Number | 868.1850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 03/16/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02336022
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|