Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K201562 |
Device Name |
Spirotrac |
Applicant |
Vitalograph Ireland Ltd. |
Gort Road Business Park |
Ennis Co Clare,
IE
V95 HFT4
|
|
Applicant Contact |
Tony O'Hanlon |
Correspondent |
Vitalograph Ireland Ltd. c/o ProMedic, LLC |
131 Bay Point Dr. NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 06/10/2020 |
Decision Date | 10/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|