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FDA 510(k)

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)

K-Number: K222213 · 2022-12-19

ApplicantUnimed Medical Supplies, Inc.
Decision Date2022-12-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) is a medical device manufactured by Unimed Medical Supplies, Inc.. It received FDA 510(k) clearance on 2022-12-19 under approval number K222213. 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 Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)?

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) is a medical device that received FDA 510(k) clearance on 2022-12-19. It is manufactured by Unimed Medical Supplies, Inc.. The 510(k) number is K222213.

When was Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) approved by the FDA?

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) received FDA 510(k) clearance on 2022-12-19, under approval number K222213.

What company makes Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)?

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) is manufactured by Unimed Medical Supplies, Inc..

What is the FDA product code for Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)?

The FDA product code for Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED NCT07527000 SpO2 Validation Study - All.Health Algo Oximeter Software COMPLETED NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Unimed Medical Supplies, Inc.

K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

View all 12 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.

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