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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 a medical device manufactured by Nonin Medical, Inc.. It received FDA 510(k) clearance on 2024-11-13 under approval 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. It is manufactured by Nonin Medical, Inc.. The 510(k) number is K211498.

When was Nonin OTC Pulse Oximeter Model 3250 approved by the FDA?

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

What company makes Nonin OTC Pulse Oximeter Model 3250?

Nonin OTC Pulse Oximeter Model 3250 is manufactured by Nonin Medical, Inc..

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

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Other Devices by Nonin Medical, Inc.

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 K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor K191403Pulse Oximeter K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface K192900H500 Multi-Sensing Oximetry System

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Related Devices (Code: OLK)

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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.

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