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FDA 510(k)

Handheld Pulse Oximeter, Model SP-20

K-Number: K172792 · 2018-11-13

ApplicantShenzhen Creative Industry Co., Ltd.
Decision Date2018-11-13
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Handheld Pulse Oximeter, Model SP-20 is a medical device manufactured by Shenzhen Creative Industry Co., Ltd.. It received FDA 510(k) clearance on 2018-11-13 under approval number K172792. 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 Handheld Pulse Oximeter, Model SP-20?

Handheld Pulse Oximeter, Model SP-20 is a medical device that received FDA 510(k) clearance on 2018-11-13. It is manufactured by Shenzhen Creative Industry Co., Ltd.. The 510(k) number is K172792.

When was Handheld Pulse Oximeter, Model SP-20 approved by the FDA?

Handheld Pulse Oximeter, Model SP-20 received FDA 510(k) clearance on 2018-11-13, under approval number K172792.

What company makes Handheld Pulse Oximeter, Model SP-20?

Handheld Pulse Oximeter, Model SP-20 is manufactured by Shenzhen Creative Industry Co., Ltd..

What is the FDA product code for Handheld Pulse Oximeter, Model SP-20?

The FDA product code for Handheld Pulse Oximeter, Model SP-20 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 Shenzhen Creative Industry Co., Ltd.

K170047All-in-One Health Monitor, PC-303 K192343Patient Monitor K201468Pulse Oximeter

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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