Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K192595 |
Device Name |
ExSpiron 2Xi |
Applicant |
Respiratory Motion |
80 Coolidge Hill Road |
Watertown,
MA
02472
|
|
Applicant Contact |
Susan K. Hamann |
Correspondent |
Respiratory Motion |
80 Coolidge Hill Road |
Watertown,
MA
02472
|
|
Correspondent Contact |
Susan K. Hamann |
Regulation Number | 868.1850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/20/2019 |
Decision Date | 12/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|