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)

Nonin OTC Pulse Oximeter Model 3250

K-Number: K211498 · 2024-11-13

ApplicantNonin Medical, Inc.
Decision Date2024-11-13
Product CodeOLK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nonin OTC Pulse Oximeter Model 3250 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 2024-11-13 under 510(k) number K211498. The device is classified under product code OLK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nonin OTC Pulse Oximeter Model 3250?

Nonin OTC Pulse Oximeter Model 3250 is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K211498.

When did Nonin OTC Pulse Oximeter Model 3250 receive FDA 510(k) clearance?

Nonin OTC Pulse Oximeter Model 3250 received FDA 510(k) clearance on 2024-11-13, under 510(k) number K211498.

Who is the listed applicant for Nonin OTC Pulse Oximeter Model 3250?

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 Nonin OTC Pulse Oximeter Model 3250?

The FDA product code for Nonin OTC Pulse Oximeter Model 3250 is OLK.

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.

NCT05995613Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of ColorCOMPLETED

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.

K192900H500 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 SystemK160865Model 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: OLK)

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.

K214115MightySat -OTCMasimo Corporation

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.

↑