FDA 510(k)

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

K-Number: K190560 · 2019-05-02

Decision Date2019-05-02

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface 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 2019-05-02 under 510(k) number K190560. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K190560.

When did SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface receive FDA 510(k) clearance?

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190560.

Who is the listed applicant for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

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 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

The FDA product code for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is MUD.

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.

NCT07335614Evaluation of Protein Loading on Measurement of Renal ReserveNOT_YET_RECRUITING NCT07349797MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart FailureRECRUITING NCT07695168Digital Course and Precision Rehabilitation for Knee Osteoarthritis and Older Adults: Integration of Multisensory Stimulation and Digital Twin TechnologyRECRUITING NCT07760129Erector Spinae Oxygen Saturation and AKI After OPCABNOT_YET_RECRUITING

Other records listing Nonin Medical, Inc. as applicant

K211498Nonin OTC Pulse Oximeter Model 3250 K192900H500 Multi-Sensing Oximetry System K191403Pulse Oximeter K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor K160231Model X-100C CO-Met™ Oximetry System K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso

View all 7 devices →

Related Devices (Code: MUD)

K254129Spectrum-2Neko Health AB K243324Masimo O3 Regional OximeterMasimo Corporation K250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences K241393ODI-TechOdi Medical AS K240601SnapshotNIR model KD205Kent Imaging, Inc.

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.