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FDA 510(k)

CPR BIO-BARRIER FACESHEILD

K-Number: K960995 · 1997-01-07

ApplicantO-Two Systems Intl., Inc.
Decision Date1997-01-07
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPR BIO-BARRIER FACESHEILD is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems Intl., Inc.. It received FDA 510(k) clearance on 1997-01-07 under 510(k) number K960995. 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 CPR BIO-BARRIER FACESHEILD?

CPR BIO-BARRIER FACESHEILD is a medical device that received FDA 510(k) clearance on 1997-01-07. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K960995.

When did CPR BIO-BARRIER FACESHEILD receive FDA 510(k) clearance?

CPR BIO-BARRIER FACESHEILD received FDA 510(k) clearance on 1997-01-07, under 510(k) number K960995.

Who is the listed applicant for CPR BIO-BARRIER FACESHEILD?

The FDA 510(k) record lists O-Two Systems Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPR BIO-BARRIER FACESHEILD?

The FDA product code for CPR BIO-BARRIER FACESHEILD 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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