Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
510(k) Number |
K223629 |
Device Name |
SpiroSphere, SpiroSphereECG, CardioSphere |
Applicant |
eResearchTechnology GmbH |
Sieboldstrasse 3 |
Estenfeld,
DE
97230
|
|
Applicant Contact |
Kristin Feld |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 868.1890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2022 |
Decision Date | 05/28/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|