Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030978

FEI Number

3002808182

Entity Name

SCHILLER AG

City/State/Country

BAAR Zug, CH

Establishment Address

ALTGASSE 68, BAAR Zug 6341, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SCHILLER AG (Owner Number: 8030978)

Owner / Operator Contact Address

ALTGASSE 68, --, BAAR, ZG, CH-ZG 6341, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K031557

PMA Number

N/A

All Registered Proprietary Names

Scale MEDILOG DARWIN HOLTER ANALYSIS medilog DARWIN2 U ARGUS PB-3000 CARDIOVIT AT-1c, AT-2c, AT-2 plus SPIROVIT SP-250 Cardiovit FT-1 Thermal paper CARDIOVIT AT-10 plus (SEMA200) Mouth piece CARDIOVIT CS-200 Excellence DS-20 CARDIOVIT AT-102 CARDIOVIT AT-101

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2017-03-28
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-07-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-07-13
LOS	N/A	N/A	Class N/A	N/A	2005-11-10
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	1981-07-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-07-24
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2017-01-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	1981-07-10
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2016-12-21
LOS	N/A	N/A	Class N/A	N/A	2005-11-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2016-06-08
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	1981-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

Ramon Martorell Business: SCHILLER AMERICAS, INC. Email: Ramon.martorell@schilleramericas.com Phone: (305) 5911121

Related Public Records

Same Entity

SCHILLER AG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030978. Last updated year: 2026. Please use registration number 8030978 when referencing this establishment in official correspondence.