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Data / Medical devices / Germany / eResearchTechnology GmbH

eResearchTechnology GmbH: FDA-registered device maker in Estenfeld Bavaria, Germany, 22 510(k) clearances

eResearchTechnology GmbH is registered with the FDA (registration 3008505660) in Estenfeld Bavaria, Germany. It lists 9 device types. The FDA files 22 510(k) clearances under its listings, the newest dated May 28, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch eResearchTechnology GmbH
FDA registration number
3008505660
Address
Sieboldstrasse 3, Estenfeld Bavaria, Germany, 97230
Owner or operator
eResearch Technology (10026366)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
July 27, 2010
Registered through
2026
Brand names listed
AM1+/AM1+ BT, AM2/AM2+, AM3 BT+, AM3 GSM, AM3 GSM/G+, AM3/AM3 BT, Asthma Monitor, Asthma Monitor AM3 G+ and more

Devices it lists

DeviceProduct codeClassRoleSource
Calculator, Predicted Values, Pulmonary FunctionBTY2Complaint file establishment, Manufactureraccessdata.fda.gov
ElectrocardiographDPS2Complaint file establishment, Manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Complaint file establishment, Manufactureraccessdata.fda.gov
Meter, Peak Flow, SpirometryBZH2Complaint file establishment, Manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Complaint file establishment, Manufactureraccessdata.fda.gov
Plethysmograph, VolumeJEH2Complaint file establishment, Manufactureraccessdata.fda.gov
Recorder, Magnetic Tape, MedicalDSH2Complaint file establishment, Manufactureraccessdata.fda.gov
Spirometer, DiagnosticBZG2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 28, 2024K223629SpiroSphere, SpiroSphereECG, CardioSphereBTYSubstantially EquivalentEresearchtechnology GmbHaccessdata.fda.gov
June 12, 2023K213754SpiroHome Personal, SpiroHome ClinicBZGSubstantially EquivalentInofab Saglik Teknolojileri A.Saccessdata.fda.gov
January 28, 2021K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUBTYSubstantially EquivalentEresearchtechnology GmbHaccessdata.fda.gov
October 3, 2019K183479Asthma Monitor AM3BZGSubstantially EquivalentEresearch Technologyaccessdata.fda.gov
February 15, 2019K173937SpiroSphereBTYSubstantially EquivalentEresearchtechnology GmbHaccessdata.fda.gov
May 8, 2014K133722ASTHMA MONITOR AM3BZGSubstantially EquivalentEresearch Technologyaccessdata.fda.gov
January 13, 2010K092890ASTHMA MONITOR AM3BZGSubstantially EquivalentCarefusion Germany 234 GmbHaccessdata.fda.gov
September 3, 2009K092324SPIROPRODQASubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
August 21, 2009K091412CLEAN PEAK FLOW METERBZHSubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
June 10, 2009K091505COR12+DSHSubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
May 6, 2009K090486ASTHMA MONITOR MODEL, AM1BZGSubstantially EquivalentCardinal Health Germany 234 GmbHaccessdata.fda.gov
December 2, 2008K082539MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CTBTYSubstantially EquivalentCardinal Health Germany 234 GmbHaccessdata.fda.gov
June 26, 2008K080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTBTYSubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
May 11, 2007K062011MODIFICATION TO FLOWSCREENBTYSubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
May 4, 2007K070614CORSCREENDPSSubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
November 14, 2003K031515SPIROPRO SPO2DQASubstantially EquivalentViasys Healthcare GmbHaccessdata.fda.gov
March 29, 2000K000648SPIRO PROBTYSubstantially EquivalentErich Jaeger GmbHaccessdata.fda.gov
August 14, 1998K980876ASTHMA MONITOR AM2BZGSubstantially EquivalentErich Jaeger GmbH & Co. KGaccessdata.fda.gov
September 20, 1996K960078ASTHMA MONITORBZGSubstantially EquivalentErich Jaeger, Inc.accessdata.fda.gov
December 14, 1995K954140MASTERSCREEN IOSBZGSubstantially EquivalentErich Jaeger GmbH & Co. KGaccessdata.fda.gov
July 31, 1995K951901MASTERSCREEN PFT BODYJEHSubstantially EquivalentErich Jaeger GmbH & Co. KGaccessdata.fda.gov
March 7, 1994K932744FLOWSCREENBTYSubstantially EquivalentErich Jaeger, Inc.accessdata.fda.gov

Compare with other makers

Updated May 28, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.