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FDA 510(k)

PLV CONTINUUM VENTILATOR, MODEL P2000

K-Number: K034032 · 2004-03-16

ApplicantRespironics California, Inc.
Decision Date2004-03-16
Product CodeNOU
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLV CONTINUUM VENTILATOR, MODEL P2000 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics California, Inc.. It received FDA 510(k) clearance on 2004-03-16 under 510(k) number K034032. The device is classified under product code NOU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLV CONTINUUM VENTILATOR, MODEL P2000?

PLV CONTINUUM VENTILATOR, MODEL P2000 is a medical device that received FDA 510(k) clearance on 2004-03-16. The listed applicant is Respironics California, Inc.. The 510(k) number is K034032.

When did PLV CONTINUUM VENTILATOR, MODEL P2000 receive FDA 510(k) clearance?

PLV CONTINUUM VENTILATOR, MODEL P2000 received FDA 510(k) clearance on 2004-03-16, under 510(k) number K034032.

Who is the listed applicant for PLV CONTINUUM VENTILATOR, MODEL P2000?

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

What is the FDA product code for PLV CONTINUUM VENTILATOR, MODEL P2000?

The FDA product code for PLV CONTINUUM VENTILATOR, MODEL P2000 is NOU.

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Other records listing Respironics California, Inc. 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.

K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODEK110795V200 INTELLI-TRAK OPTIONK102054V200 VENTILATORK082660V60 VENTILATOR, MODEL V8000K072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

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Related Devices (Code: NOU)

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.

K233452Vivo 45 LSBreas Medical ABK193586Vivo 45 LSBreas Medical ABK160481Vivo 60Breas Medical ABK123144VIVO 50Ge Healthcare, Breas Medical ABK022750PLV CONTINUUM VENTILATOR, MODEL P1000Respironics California, Inc.K021981IVENT 201 PORTABLE VENTILATORVersamed , 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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