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FDA 510(k)

SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

K-Number: K963755 · 1997-04-08

ApplicantSpiracle Technology
Decision Date1997-04-08
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR is the device name listed in this FDA 510(k) record. The listed applicant is Spiracle Technology. It received FDA 510(k) clearance on 1997-04-08 under 510(k) number K963755. 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 TECHNOLOGY - MODEL 302 OX INHALATOR?

SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR is a medical device that received FDA 510(k) clearance on 1997-04-08. The listed applicant is Spiracle Technology. The 510(k) number is K963755.

When did SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR receive FDA 510(k) clearance?

SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR received FDA 510(k) clearance on 1997-04-08, under 510(k) number K963755.

Who is the listed applicant for SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR?

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 TECHNOLOGY - MODEL 302 OX INHALATOR?

The FDA product code for SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR is CBP.

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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 MONITORK953349SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

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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