Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
510(k) Number |
K173937 |
Device Name |
SpiroSphere |
Applicant |
eResearchTechnology GmbH |
Sieboldstrasse 3 |
Estenfeld,
DE
97230
|
|
Applicant Contact |
Johannes Thalhammer |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
DAWN M TIBODEAU |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 12/26/2017 |
Decision Date | 02/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|