Hamilton Medical AG

FDA Device Registration & Listing · Domat/Ems Graubunden, CH · Registration 3029906224

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029906224
FEI Number
3029906224
Entity Name
Hamilton Medical AG
City/State/Country
Domat/Ems Graubunden, CH
Establishment Address
Parc Industrial Vial 12, Domat/Ems Graubunden 7013, CH
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Hamilton Medical AG (Owner Number: 10059168)
Owner / Operator Contact Address
Via Crusch 8, Bonaduz, CH-GR 7402, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201306
PMA Number
N/A

All Registered Proprietary Names

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 Ventilair II Medical Air Compressor HAMILTON-C6 HAMILTON-MR1 HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 Expiratory valve set , reusable, PN 161175, PN 161188, PN 151972, PN 160245 Expiratory valve set , single use, PN 160176, PN 161186, PN 161189, PN 950158 Flow sensor, single use, neonatal PN 260179, PN 260177, PN 155500 Flow sensor, single use, neonatal/adult/pediatric PN 282049 Flow sensor, single use, adult/pediatric PN 282051, PN 281637, PN 950185 HAMILTON-T1, HAMILTON-C1 HAMILTON-G5 HAMILTON-C3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2019-06-18
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2021-07-22
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2021-01-12
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2019-06-18
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2019-06-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2019-06-18
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2021-02-19
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2019-10-24
DQA Oximeter Cardiovascular Class 2 870.2700 2019-10-24
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2019-10-24
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-05-13
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2021-02-19

Official Correspondent

Annemarie Hoeft

US Agent Details

Kyle Hofer Business: Hamilton Medical, Inc. Email: kyle.hofer@hamiltonmedical.com Phone: (800) 4516478

Related Public Records

Same Entity

Hamilton Medical AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3001421318 HAMILTON MEDICAL AG BONADUZ Graubunden, CH
3014766741 Hamilton Medical AG Domat / Ems Graubunden, CH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16
K900686 Medical Industries America, Inc. MAXI COMPRESSORS 1990-04-26
K051895 Datex-Ohmeda, Inc. GE DATEX-OHMEDA ENGSTROM CARESTATION 2005-09-27
K082966 Covidien, Formerly Nellcor Puritan Bennett, Inc. PB 540 VENTILATOR 2008-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2015 Respironics California Inc 2
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011 Draeger Medical Systems, Inc. 2
Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015 Nellcor Puritan Bennett Inc. (dba Covidien LP) 2
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015 Nellcor Puritan Bennett Inc. (dba Covidien LP) 2
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022 Covidien Llc 2
Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029906224. Last updated year: 2026. Please use registration number 3029906224 when referencing this establishment in official correspondence.
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