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FDA 510(k)

BERNOULLI ENTERPRISE SOFTWARE

K-Number: K130208 · 2013-12-20

ApplicantCardiopulmonary Corp.
Decision Date2013-12-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BERNOULLI ENTERPRISE SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiopulmonary Corp.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K130208. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERNOULLI ENTERPRISE SOFTWARE?

BERNOULLI ENTERPRISE SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Cardiopulmonary Corp.. The 510(k) number is K130208.

When did BERNOULLI ENTERPRISE SOFTWARE receive FDA 510(k) clearance?

BERNOULLI ENTERPRISE SOFTWARE received FDA 510(k) clearance on 2013-12-20, under 510(k) number K130208.

Who is the listed applicant for BERNOULLI ENTERPRISE SOFTWARE?

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 ENTERPRISE SOFTWARE?

The FDA product code for BERNOULLI ENTERPRISE SOFTWARE is MHX.

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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.

K091461BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUEK061932BERNOULLI 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: MHX)

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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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