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FDA 510(k)

PARAPAC

K-Number: K960515 · 1996-10-10

ApplicantPneupac , Ltd.
Decision Date1996-10-10
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PARAPAC is the device name listed in this FDA 510(k) record. The listed applicant is Pneupac , Ltd.. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K960515. 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 PARAPAC?

PARAPAC is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Pneupac , Ltd.. The 510(k) number is K960515.

When did PARAPAC receive FDA 510(k) clearance?

PARAPAC received FDA 510(k) clearance on 1996-10-10, under 510(k) number K960515.

Who is the listed applicant for PARAPAC?

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 PARAPAC?

The FDA product code for PARAPAC is BTL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 P200DK863410PATIENT VALVE WITH AIR ENTRAINMENTK862830MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR

View all 19 devices →

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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