FDA 510(k)

PNEUPAC INSTANT ACTION VENTILATOR/RESUS

K-Number: K843737 · 1984-10-04

Decision Date1984-10-04

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PNEUPAC INSTANT ACTION VENTILATOR/RESUS is the device name listed in this FDA 510(k) record. The listed applicant is Pneupac , Ltd.. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K843737. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUPAC INSTANT ACTION VENTILATOR/RESUS?

PNEUPAC INSTANT ACTION VENTILATOR/RESUS is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Pneupac , Ltd.. The 510(k) number is K843737.

When did PNEUPAC INSTANT ACTION VENTILATOR/RESUS receive FDA 510(k) clearance?

PNEUPAC INSTANT ACTION VENTILATOR/RESUS received FDA 510(k) clearance on 1984-10-04, under 510(k) number K843737.

Who is the listed applicant for PNEUPAC INSTANT ACTION VENTILATOR/RESUS?

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 PNEUPAC INSTANT ACTION VENTILATOR/RESUS?

The FDA product code for PNEUPAC INSTANT ACTION VENTILATOR/RESUS is CBK.

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Other records listing Pneupac , Ltd. as applicant

K040090COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)K030803PARAPAC 200D TRANSPORT, MODEL V200D K021841COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER K020899PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D K960515PARAPAC K863410PATIENT VALVE WITH AIR ENTRAINMENT

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Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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.