Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001421318

FEI Number

3001421318

Entity Name

HAMILTON MEDICAL AG

City/State/Country

BONADUZ Graubunden, CH

Establishment Address

VIA CRUSCH 8, BONADUZ Graubunden 7402, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

PMA Number

N/A

All Registered Proprietary Names

HAMILTON-T1, HAMILTON-C1 HAMILTON-C6 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-H900, HAMILTON-BC8010, HAMILTON-BC4010 HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2021-01-12
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2021-02-19
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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2019-06-18
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2022-07-27

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
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3014766741	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
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
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31

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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3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001421318. Last updated year: 2026. Please use registration number 3001421318 when referencing this establishment in official correspondence.