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FDA 510(k)

FACE-2-FACE CPR PROTECTION SHIELD

K-Number: K991617 · 1999-11-03

ApplicantWhiteline Plastics, Inc.
Decision Date1999-11-03
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FACE-2-FACE CPR PROTECTION SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Whiteline Plastics, Inc.. It received FDA 510(k) clearance on 1999-11-03 under 510(k) number K991617. 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 FACE-2-FACE CPR PROTECTION SHIELD?

FACE-2-FACE CPR PROTECTION SHIELD is a medical device that received FDA 510(k) clearance on 1999-11-03. The listed applicant is Whiteline Plastics, Inc.. The 510(k) number is K991617.

When did FACE-2-FACE CPR PROTECTION SHIELD receive FDA 510(k) clearance?

FACE-2-FACE CPR PROTECTION SHIELD received FDA 510(k) clearance on 1999-11-03, under 510(k) number K991617.

Who is the listed applicant for FACE-2-FACE CPR PROTECTION SHIELD?

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

What is the FDA product code for FACE-2-FACE CPR PROTECTION SHIELD?

The FDA product code for FACE-2-FACE CPR PROTECTION SHIELD is CBP.

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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.

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