Seal Rite Non-Rebreathing Valve
K-Number: K152521 · 2016-06-03
ApplicantThe Lifeguard Store, Inc.
Decision Date2016-06-03
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Seal Rite Non-Rebreathing Valve is a medical device manufactured by The Lifeguard Store, Inc.. It received FDA 510(k) clearance on 2016-06-03 under approval number K152521. 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 Seal Rite Non-Rebreathing Valve?
Seal Rite Non-Rebreathing Valve is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by The Lifeguard Store, Inc.. The 510(k) number is K152521.
When was Seal Rite Non-Rebreathing Valve approved by the FDA?
Seal Rite Non-Rebreathing Valve received FDA 510(k) clearance on 2016-06-03, under approval number K152521.
What company makes Seal Rite Non-Rebreathing Valve?
Seal Rite Non-Rebreathing Valve is manufactured by The Lifeguard Store, Inc..
What is the FDA product code for Seal Rite Non-Rebreathing Valve?
The FDA product code for Seal Rite Non-Rebreathing Valve is CBP.
Related Devices (Code: CBP)
K171961Compower 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)Xiamen Compower Medical Tech. Co., Ltd.
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.