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FDA 510(k)

CPR MASK & RELATED FAMILY KITS

K-Number: K953461 · 1996-01-04

ApplicantSafetec of America, Inc.
Decision Date1996-01-04
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPR MASK & RELATED FAMILY KITS is the device name listed in this FDA 510(k) record. The listed applicant is Safetec of America, Inc.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K953461. 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 MASK & RELATED FAMILY KITS?

CPR MASK & RELATED FAMILY KITS is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Safetec of America, Inc.. The 510(k) number is K953461.

When did CPR MASK & RELATED FAMILY KITS receive FDA 510(k) clearance?

CPR MASK & RELATED FAMILY KITS received FDA 510(k) clearance on 1996-01-04, under 510(k) number K953461.

Who is the listed applicant for CPR MASK & RELATED FAMILY KITS?

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

What is the FDA product code for CPR MASK & RELATED FAMILY KITS?

The FDA product code for CPR MASK & RELATED FAMILY KITS is CBP.

Related Clinical Trials

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.

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Other records listing Safetec of America, Inc. as applicant

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.

K960048EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUSK960073EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UPK952962EZ-PERSONAL PROTECTION KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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