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FDA 510(k)

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

K-Number: K091461 · 2009-08-14

ApplicantCardiopulmonary Corp.
Decision Date2009-08-14
Product CodeMOD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiopulmonary Corp.. It received FDA 510(k) clearance on 2009-08-14 under 510(k) number K091461. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE?

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE is a medical device that received FDA 510(k) clearance on 2009-08-14. The listed applicant is Cardiopulmonary Corp.. The 510(k) number is K091461.

When did BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE receive FDA 510(k) clearance?

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE received FDA 510(k) clearance on 2009-08-14, under 510(k) number K091461.

Who is the listed applicant for BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE?

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

What is the FDA product code for BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE?

The FDA product code for BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE is MOD.

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Other records listing Cardiopulmonary Corp. 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.

K130208BERNOULLI ENTERPRISE SOFTWAREK061932BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWAREK051283MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWAREK020018MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWAREK011861BERNOULLI VENTILATOR MANAGEMENT SYSTEMK990429MODIFICATION OF VENTURI VENTILATOR

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Related Devices (Code: MOD)

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.

K261360EasyCare Tx 2Resmed CorpK253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences , Ltd.K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.K242485EveryWareBreas Medical ABK161411Care Cycle Connect ApplicationRespironics, Inc.K052751VENTLINK SYSTEMMediserve Information Systems, Inc.

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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