Eresearchtechnology GmbH

FDA Regulatory Profile

Eresearchtechnology GmbH appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 28, 2024.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223629SpiroSphere, SpiroSphereECG, CardioSphereMay 28, 2024
K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUJanuary 28, 2021
K173937SpiroSphereFebruary 15, 2019