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FDA 510(k)

PNEU PAC VENTILATOR/RESUSCITATORS

K-Number: K832700 · 1983-11-14

ApplicantPneupac , Ltd.
Decision Date1983-11-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEU PAC VENTILATOR/RESUSCITATORS is the device name listed in this FDA 510(k) record. The listed applicant is Pneupac , Ltd.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832700. 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 PNEU PAC VENTILATOR/RESUSCITATORS?

PNEU PAC VENTILATOR/RESUSCITATORS is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Pneupac , Ltd.. The 510(k) number is K832700.

When did PNEU PAC VENTILATOR/RESUSCITATORS receive FDA 510(k) clearance?

PNEU PAC VENTILATOR/RESUSCITATORS received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832700.

Who is the listed applicant for PNEU PAC VENTILATOR/RESUSCITATORS?

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 PNEU PAC VENTILATOR/RESUSCITATORS?

The FDA product code for PNEU PAC VENTILATOR/RESUSCITATORS is CBK.

Related Clinical Trials

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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

View all 19 devices →

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP 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.

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