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)

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

K-Number: K171961 · 2017-11-17

ApplicantXiamen Compower Medical Tech. Co., Ltd.
Decision Date2017-11-17
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is a medical device manufactured by Xiamen Compower Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under approval number K171961. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)?

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Xiamen Compower Medical Tech. Co., Ltd.. The 510(k) number is K171961.

When was Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) approved by the FDA?

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) received FDA 510(k) clearance on 2017-11-17, under approval number K171961.

What company makes Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)?

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is manufactured by Xiamen Compower Medical Tech. Co., Ltd..

What is the FDA product code for Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)?

The FDA product code for Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is CBP.

Related Clinical Trials

NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT07615738 SpO2 Infant and Pediatric Study NOT_YET_RECRUITING NCT07610642 Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers NOT_YET_RECRUITING NCT07588399 STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI NOT_YET_RECRUITING NCT05526560 Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve ACTIVE_NOT_RECRUITING NCT07317401 Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to Improve Fatigue, Pain, and Quality of Life by Targeting Mitochondrial Dysfunction and Autonomic Nervous System Impairment NOT_YET_RECRUITING

Other Devices by Xiamen Compower Medical Tech. Co., Ltd.

K210288Disposable Manual Resuscitator

Related Devices (Code: CBP)

K152521Seal Rite Non-Rebreathing ValveThe Lifeguard Store, Inc. K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare Limited K192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou) K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic AS K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbH K234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, 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.

↑