Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014766741

FEI Number

3014766741

Entity Name

Hamilton Medical AG

City/State/Country

Domat / Ems Graubunden, CH

Establishment Address

Parc lndustrial Vial 10, Domat / Ems Graubunden 7013, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hamilton Medical AG (Owner Number: 10059168)

Owner / Operator Contact Address

Via Crusch 8, Bonaduz, CH-GR 7402, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150893

PMA Number

N/A

All Registered Proprietary Names

Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206 Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087 Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 260169, PN 260170 Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257 Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244 HAMILTON-G5 HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 HAMILTON-C3 HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 HAMILTON-T1, HAMILTON-C1 HAMILTON-MR1 HAMILTON-C2 HAMILTON-C6 IntelliCuff

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2022-07-27
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-05-13
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
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2021-02-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2019-06-18
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	2019-06-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2019-06-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2021-01-12
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2019-06-18

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
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
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.

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3015277818	HANGZHOU WEIZE IMP & EXP CO., LTD	Hangzhou Zhejiang, CN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014766741. Last updated year: 2026. Please use registration number 3014766741 when referencing this establishment in official correspondence.