Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K163249 |
Device Name |
GoSpiro |
Applicant |
MONITORED THERAPEUTICS, INC. |
5940 VENTURE DR., SUITE C |
DUBLIN,
OH
43017
|
|
Applicant Contact |
William Zimlich |
Correspondent |
PROMEDIC, LLC |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/18/2016 |
Decision Date | 03/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|