A-M Systems

FDA Device Registration & Listing · Sequim, WA, US · Registration 3020614

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
3020614
FEI Number
3020614
Entity Name
A-M Systems
City/State/Country
Sequim, WA, US
Establishment Address
131 BUSINESS PARK LOOP, Sequim, WA 98382, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
A-M SYSTEMS, LLC (Owner Number: 3020614)
Owner / Operator Contact Address
131 BUSINESS PARK LOOP, Sequim, WA 98382, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 VARIOUS SIZES OF NON-STERILE RUBBER RE-USEABLE MOUTHPIECE OXYGEN FLOWMETER ANESTHESIA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2013-07-24
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 1992-06-30
EPN Pump, Nebulizer, Manual Ear, Nose, Throat Class 1 874.5220 1992-06-30
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2019-12-20
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2007-11-26
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2019-12-17
BXW Calibrator, Volume, Gas Anesthesiology Class 1 868.1870 1992-06-30
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 1992-06-30
BXJ Clip, Nose Anesthesiology Class 1 868.6225 1992-06-30
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 1992-06-30
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 1992-06-30
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2001-05-29
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated Anesthesiology Class 1 868.2340 1984-10-05

Official Correspondent

ROBERT THOMPSON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

A-M SYSTEMS, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26
K770946 Instrumentation Laboratory CO RECORD, MODEL 702, I.L. 1977-07-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020614. Last updated year: 2026. Please use registration number 3020614 when referencing this establishment in official correspondence.
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