Last synced on 5 July 2024 at 11:05 pm

SpiroSphere, SpiroSphereECG, CardioSphere

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223629
510(k) Type
Traditional
Applicant
eResearchTechnology GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
5/28/2024
Days to Decision
540 days
Submission Type
Summary

SpiroSphere, SpiroSphereECG, CardioSphere

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223629
510(k) Type
Traditional
Applicant
eResearchTechnology GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
5/28/2024
Days to Decision
540 days
Submission Type
Summary