Schiller, AG
BAAR Zug, CH
SCHILLER AG appears in FDA device records in BAAR Zug, CH. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Schiller, AG between 1985 and 2026. The busiest year on record is 1985, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1987 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253562 | medilogFD | MWJ | Substantially Equivalent | |
| K221056 | ARGUS PB-3000 | MHX | Substantially Equivalent | |
| K183425 | CARDIOVIT AT-102 G2 | DPS | Substantially Equivalent | |
| K170182 | CARDIOVIT FT-1 | DPS | Substantially Equivalent | |
| K152043 | Diagnostic Station DS20 | DPS | Substantially Equivalent | |
| K101619 | WELCH ALLYN 1500 PATIENT MONITOR | MHX | Substantially Equivalent | |
| K063814 | BP-200 PLUS | DXN | Substantially Equivalent | |
| K053207 | ARGUS, MODEL LCM | MHX | Substantially Equivalent | |
| K051368 | BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM | DXN | Substantially Equivalent | |
| K050686 | CARDIOVIT AT-10PLUS | DPS | Substantially Equivalent | |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | DSK | Substantially Equivalent | |
| K031557 | CARDIOVIT AT-102 | DPS | Substantially Equivalent | |
| K012226 | MONITORING SYSTEM,MODEL ARGUS PB-1000 | MHX | Substantially Equivalent | |
| K992823 | SPIROVIT SP-2, PNEUMOCHECK II | BZG | Substantially Equivalent | |
| K984031 | SPIROVIT, MODEL SP-250 | BZG | Substantially Equivalent | |
| K864465 | CARDIOVIT AT-6 | DPS | Substantially Equivalent | |
| K850702 | CARDIOVIT CS-6 ECG-RECORDER | DPS | Substantially Equivalent | |
| K841254 | CARDIOVIT CV-3 | DPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030978 | 3002808182 | SCHILLER AG | ALTGASSE 68, BAAR Zug 6341 CH | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LIXAid, Cardiopulmonary Resuscitation
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- BYPMouthpiece, Breathing
- DQAOximeter
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- FRIScale, Stand-On, Patient
- BZGSpirometer, Diagnostic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2672-2025 | Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 | Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range. | Class II | Open, Classified | |
| Z-2734-2024 | CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 | Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain