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FDA 510(k)

MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR

K-Number: K862830 · 1986-10-15

ApplicantPneupac , Ltd.
Decision Date1986-10-15
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Pneupac , Ltd.. It received FDA 510(k) clearance on 1986-10-15 under 510(k) number K862830. 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 MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR?

MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1986-10-15. The listed applicant is Pneupac , Ltd.. The 510(k) number is K862830.

When did MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR receive FDA 510(k) clearance?

MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR received FDA 510(k) clearance on 1986-10-15, under 510(k) number K862830.

Who is the listed applicant for MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR?

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

What is the FDA product code for MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR?

The FDA product code for MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR is BTL.

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Other records listing Pneupac , Ltd. 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.

K040090COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)K030803PARAPAC 200D TRANSPORT, MODEL V200DK021841COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGERK020899PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200DK960515PARAPACK863410PATIENT VALVE WITH AIR ENTRAINMENT

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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

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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