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FDA 510(k)

SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

K-Number: K953349 · 1996-02-29

ApplicantSpiracle Technology
Decision Date1996-02-29
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Spiracle Technology. It received FDA 510(k) clearance on 1996-02-29 under 510(k) number K953349. 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 SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE?

SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE is a medical device that received FDA 510(k) clearance on 1996-02-29. The listed applicant is Spiracle Technology. The 510(k) number is K953349.

When did SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE receive FDA 510(k) clearance?

SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE received FDA 510(k) clearance on 1996-02-29, under 510(k) number K953349.

Who is the listed applicant for SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE?

The FDA 510(k) record lists Spiracle Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE?

The FDA product code for SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE 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 Spiracle Technology 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.

K982225SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504K973347TSX PRM PULMONARY RESUSCITATION MONITORK963755SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

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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