Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

K-Number: K092101 · 2009-10-21

ApplicantNonin Medical, Inc.
Decision Date2009-10-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2009-10-21 under 510(k) number K092101. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES?

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K092101.

When did REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES receive FDA 510(k) clearance?

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES received FDA 510(k) clearance on 2009-10-21, under 510(k) number K092101.

Who is the listed applicant for REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES?

The FDA 510(k) record lists Nonin Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES?

The FDA product code for REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES is DQA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nonin Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211498Nonin OTC Pulse Oximeter Model 3250K192900H500 Multi-Sensing Oximetry SystemK191403Pulse OximeterK190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InterfaceK172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorK160231Model X-100C CO-Met™ Oximetry System

View all 47 devices →

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑