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FDA 510(k)

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

K-Number: K922933 · 1992-11-30

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1992-11-30
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1992-11-30 under 510(k) number K922933. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORIN MONOLYRH INTEGRATED MEMBRANE LUNG?

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG is a medical device that received FDA 510(k) clearance on 1992-11-30. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K922933.

When did SORIN MONOLYRH INTEGRATED MEMBRANE LUNG receive FDA 510(k) clearance?

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG received FDA 510(k) clearance on 1992-11-30, under 510(k) number K922933.

Who is the listed applicant for SORIN MONOLYRH INTEGRATED MEMBRANE LUNG?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SORIN MONOLYRH INTEGRATED MEMBRANE LUNG?

The FDA product code for SORIN MONOLYRH INTEGRATED MEMBRANE LUNG is DTZ.

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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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