Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008505660

FEI Number

3008505660

Entity Name

eResearchTechnology GmbH

City/State/Country

Estenfeld Bavaria, DE

Establishment Address

Sieboldstrasse 3, Estenfeld Bavaria 97230, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

eResearch Technology (Owner Number: 10026366)

Owner / Operator Contact Address

1818 Market Street, Suite 2600, Philadelphia, PA 19103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K000648

PMA Number

N/A

All Registered Proprietary Names

Clear Peak Flow Meter Masterscreen PFT CT Asthma Monitor DIARYpro My Data Uploader ERT eCOA System ERT ePRO System ERT LogPad System EXPERT, EXPERT ePRO, EXPERT Central, EXPERT Research and Integration Platform Flowscreen SpiroPro SP02 Flowscreen with ECG Mouthpiece, 30 pieces SpiroPro with BT & Sp02 Masterscreen IOS CT SpiroSphere ECG SpiroSphere CardioSphere AM1+/AM1+ BT AM3/AM3 BT CorScreen SpiroSphere Cor12+ Asthma Monitor AMOS App Asthma Monitor AM3 G+ Flowscreen Masterscope ECG SpiroPro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2011-01-07
JEH	Plethysmograph, Volume	Anesthesiology	Class 2	868.1760	2010-07-27
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2010-07-27
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2012-01-16
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2010-07-27
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2011-01-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-01-07
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2010-07-27
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2010-07-27
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-10-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-07-27
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2010-07-27
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2010-07-27
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2024-06-03
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-06-03
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2011-01-07
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2011-01-07
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2010-07-27
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2019-02-19
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2011-01-07
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2019-10-24
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2011-01-07
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2011-01-07
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-01-07
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2011-01-07

Official Correspondent

Todd Kisner

US Agent Details

Todd Kisner Business: ERESEARCH TECHNOLOGY Email: todd.kisner@clario.com Phone: (609) 9364594

Related Public Records

Same Entity

eResearch Technology

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009553578	APDM Wearable Technologies, Inc.	Portland, OR, US
2916493	eResearchTechnology, Inc.	Philadelphia, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008505660. Last updated year: 2026. Please use registration number 3008505660 when referencing this establishment in official correspondence.