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)

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable

K-Number: K201179 · 2020-07-20

ApplicantCovidien, LLC
Decision Date2020-07-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2020-07-20 under approval number K201179. 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 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable?

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable is a medical device that received FDA 510(k) clearance on 2020-07-20. It is manufactured by Covidien, LLC. The 510(k) number is K201179.

When was GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable approved by the FDA?

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable received FDA 510(k) clearance on 2020-07-20, under approval number K201179.

What company makes GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable?

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable is manufactured by Covidien, LLC.

What is the FDA product code for GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable?

The FDA product code for GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable is DQA.

Other Devices by Covidien, LLC

K163105Emprint Ablation System K163098Tri-Staple 2.0 Intelligent Cartridge K160290Valleylab REM Polyhesive Infant Patient Return Electrode K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) K152794Cytosponge Cell Collection Device K160360Barrx FLEX RFA Energy Generator

View all 57 devices →

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.

↑