Device Classification Name |
Spirometer, Monitoring (W/Wo Alarm)
|
510(k) Number |
K120087 |
FOIA Releasable 510(k) |
K120087
|
Device Name |
EXSPIRON |
Applicant |
RESPIRATORY MOTION, INC. |
411 WAVERLY OAKS ROAD |
BUILDING 1, SUITE 150 |
WALTHAM,
MA
02452
|
|
Applicant Contact |
CHAS BURR |
Correspondent |
RESPIRATORY MOTION, INC. |
411 WAVERLY OAKS ROAD |
BUILDING 1, SUITE 150 |
WALTHAM,
MA
02452
|
|
Correspondent Contact |
CHAS BURR |
Regulation Number | 868.1850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/11/2012 |
Decision Date | 09/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|