Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K191013 |
Device Name |
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option |
Applicant |
Welch Allyn, Inc. |
7865 North 86th St. |
Milwaukee,
WI
53224
|
|
Applicant Contact |
Megan Pellenz |
Correspondent |
Welch Allyn, Inc. |
7865 North 86th St. |
Milwaukee,
WI
53224
|
|
Correspondent Contact |
Megan Pellenz |
Regulation Number | 868.1840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/17/2019 |
Decision Date | 09/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|