Medical Device Manufacturer · US , Bonita Springs , FL

I.E.M. GmbH - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2004

Recent clearances: ABPM 7100, Hypertension Management Software, ABPM7100, HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - I.E.M. GmbH Cardiovascular ✕

5 devices

1-5 of 5

Cleared Jul 19, 2016

ABPM 7100, Hypertension Management Software

Cardiovascular · 218d

Cleared Sep 15, 2014

Cardiovascular · 157d

Cleared Dec 16, 2011

HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)

Cardiovascular · 288d

Cleared Nov 29, 2007

MOBIL-O-GRAPH NG 24 H ABP-CONTROL

Cardiovascular · 91d

Cleared Jun 18, 2004

Cardiovascular · 32d