A-M Systems

Reg #: 3020614 · FEI: 3020614 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: A-M Systems
Registration Number: 3020614
FEI Number: 3020614
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 131 BUSINESS PARK LOOP
City: Sequim
State: WA
ZIP: 98382
Country: US

Regulatory Submissions

510(k) Number: K130664

Owner / Operator

Firm Name: A-M SYSTEMS, LLC
Operator Number: 3020614
Address: 131 BUSINESS PARK LOOP
City: Sequim
State: WA
Postal Code: 98382
Country: US
Correspondent: ROBERT J THOMPSON

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Filter, Bacterial, Breathing-Circuit	CAH	Class 2	Anesthesiology	No	2013-07-24
Cannula, Nasal, Oxygen	CAT	Class 1	Anesthesiology	No	1992-06-30
Pump, Nebulizer, Manual	EPN	Class 1	Ear, Nose, Throat	No	1992-06-30
Connector, Airway (Extension)	BZA	Class 1	Anesthesiology	No	2019-12-20
Bag, Reservoir	BTC	Class 1	Anesthesiology	No	2019-12-17
Calibrator, Volume, Gas	BXW	Class 1	Anesthesiology	No	1992-06-30
Tubing, Pressure And Accessories	BYX	Class 1	Anesthesiology	No	1992-06-30
Clip, Nose	BXJ	Class 1	Anesthesiology	No	1992-06-30
Recorder, Paper Chart	DSF	Class 1	Cardiovascular	No	1992-06-30
Mouthpiece, Breathing	BYP	Class 1	Anesthesiology	No	1992-06-30
Mask, Oxygen	BYG	Class 1	Anesthesiology	No	2001-05-29
Flowmeter, Tube, Thorpe, Back-Pressure Compensated	CAX	Class 1	Anesthesiology	No	1984-10-05
Absorber, Carbon-Dioxide	BSF	Class 1	Anesthesiology	No	1992-06-30

Proprietary Names

HydroMax HMEF OXYGEN MEDICINAL NEBULIZER Nut and Nipple, Swivel Connector VBMax BAG, BREATHING CAL-SYRINGE LOW PRESSURE TUBIN VARIOUS SIZES OF NON-STERILE PLASTIC DISPOSABLE NOSECLIP VARIOUS SIZES OF RECO NON-STERILE PLASTIC R RUBBER RE-USEABLE MOUTHPIECE FLOWMETER ANESTHESIA EasyOne Filter FT EasyOne Filter SP ViroMax ABSORBER CARBON DIOXIDE

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device