NONIN MEDICAL, INC.

FDA Device Registration & Listing · Plymouth, MN, US · Registration 2183646

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
2183646
FEI Number
2183646
Entity Name
NONIN MEDICAL, INC.
City/State/Country
Plymouth, MN, US
Establishment Address
13700 1ST AVE, NORTH, Plymouth, MN 55441, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NONIN MEDICAL, INC. (Owner Number: 2183646)
Owner / Operator Contact Address
13700 1ST AVE, NORTH, --, Plymouth, MN 55441, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K071415
PMA Number
N/A

All Registered Proprietary Names

Model 9600 Model 9700 nVision Data Management Nonin Connect App eVision Model 3245 8100SL X-100SP X-100M SenSmart Equanox 8100SS 8100SM X-100 X-100Hub INT-100 Onyx Vantage 9590 Model 9847 Model 9843 Model 3100 Model 8000A(X)-WO Model 8000A(X)-WO2 Model 3150 Model 3230 Model 3231 Model 3240 Regional Oximetry Sensor Sensor, 6500 Series Model 8101AA/8101AP Sensors, Model 8102AA/8102AP Sensors, Model 8100Q2 Sensor, Model 8101Q2 Sensor, Model 8102Q2 Sensor Model 6100C Series Sensors, Model 6101C Series Sensors, Model 6102C Series Sensors, Model 8100AA/8100AP Sensors, 8500 Series Sensors, 8000 Soft Series FILTER MOISTURE TRAP PulseSense LifeSense RespSense Model 4100 3231 Pulse Oximeter Model 4000 8000Q2 Model 7500 Model 8000J Series Model 8000A(X) Series Avant Model 2120 8000FC Sensor 8000FI Sensor Model 7500FO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
OUG Medical Device Data System General Hospital Class 1 880.6310 2020-03-12
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2020-01-21
DQA Oximeter Cardiovascular Class 2 870.2700 2014-03-18
DQA Oximeter Cardiovascular Class 2 870.2700 2019-11-15
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2007-12-18
DQA Oximeter Cardiovascular Class 2 870.2700 2007-12-18
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2013-10-23
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2019-11-06
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2016-09-08
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2016-09-08
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2019-07-15
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2015-08-27
DQA Oximeter Cardiovascular Class 2 870.2700 2020-08-26
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-18
DQA Oximeter Cardiovascular Class 2 870.2700 2007-12-18
DQA Oximeter Cardiovascular Class 2 870.2700 2012-01-12

Official Correspondent

John Melquist

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NONIN MEDICAL, INC.
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
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
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183646. Last updated year: 2026. Please use registration number 2183646 when referencing this establishment in official correspondence.
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