Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is The Lifeguard Store, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) 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. The listed applicant is The Lifeguard Store, Inc.. The 510(k) number is K152521.

When did Seal Rite Non-Rebreathing Valve receive FDA 510(k) clearance?

Seal Rite Non-Rebreathing Valve received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152521.

Who is the listed applicant for Seal Rite Non-Rebreathing Valve?

The FDA 510(k) record lists The Lifeguard Store, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower 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.

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.

↑