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FDA 510(k)

PULMODYNE CHF FLOW GENERATOR SYSTEM

K-Number: K080256 · 2008-05-09

ApplicantPulmodyne
Decision Date2008-05-09
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMODYNE CHF FLOW GENERATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pulmodyne. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K080256. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMODYNE CHF FLOW GENERATOR SYSTEM?

PULMODYNE CHF FLOW GENERATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Pulmodyne. The 510(k) number is K080256.

When did PULMODYNE CHF FLOW GENERATOR SYSTEM receive FDA 510(k) clearance?

PULMODYNE CHF FLOW GENERATOR SYSTEM received FDA 510(k) clearance on 2008-05-09, under 510(k) number K080256.

Who is the listed applicant for PULMODYNE CHF FLOW GENERATOR SYSTEM?

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

What is the FDA product code for PULMODYNE CHF FLOW GENERATOR SYSTEM?

The FDA product code for PULMODYNE CHF FLOW GENERATOR SYSTEM is BYE.

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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