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FDA 510(k)

SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504

K-Number: K982225 · 1998-10-28

ApplicantSpiracle Technology
Decision Date1998-10-28
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 is the device name listed in this FDA 510(k) record. The listed applicant is Spiracle Technology. It received FDA 510(k) clearance on 1998-10-28 under 510(k) number K982225. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504?

SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Spiracle Technology. The 510(k) number is K982225.

When did SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 receive FDA 510(k) clearance?

SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 received FDA 510(k) clearance on 1998-10-28, under 510(k) number K982225.

Who is the listed applicant for SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504?

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-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504?

The FDA product code for SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 is BTL.

Related Clinical Trials

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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.

K973347TSX PRM PULMONARY RESUSCITATION MONITORK963755SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATORK953349SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

Related Devices (Code: BTL)

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.

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO KgaaK221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KGK182956Puffin Lite Infant Resuscitation SystemInternational BiomedicalK173373SafeT T-Piece ResuscitatorVentlab, LLC

Official Source

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