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

FDA 510(k)

Nasal Alar SpO2 Sensor

K-Number: K171423 · 2017-07-27

ApplicantXhale, Inc.
Decision Date2017-07-27
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nasal Alar SpO2 Sensor is a medical device manufactured by Xhale, Inc.. It received FDA 510(k) clearance on 2017-07-27 under approval number K171423. 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 Nasal Alar SpO2 Sensor?

Nasal Alar SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2017-07-27. It is manufactured by Xhale, Inc.. The 510(k) number is K171423.

When was Nasal Alar SpO2 Sensor approved by the FDA?

Nasal Alar SpO2 Sensor received FDA 510(k) clearance on 2017-07-27, under approval number K171423.

What company makes Nasal Alar SpO2 Sensor?

Nasal Alar SpO2 Sensor is manufactured by Xhale, Inc..

What is the FDA product code for Nasal Alar SpO2 Sensor?

The FDA product code for Nasal Alar SpO2 Sensor is DQA.

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology 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.

↑