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FDA 510(k)

NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG

K-Number: K072362 · 2007-10-23

ApplicantNovalung GmbH
Decision Date2007-10-23
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG is the device name listed in this FDA 510(k) record. The listed applicant is Novalung GmbH. It received FDA 510(k) clearance on 2007-10-23 under 510(k) number K072362. 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 NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG?

NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG is a medical device that received FDA 510(k) clearance on 2007-10-23. The listed applicant is Novalung GmbH. The 510(k) number is K072362.

When did NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG receive FDA 510(k) clearance?

NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG received FDA 510(k) clearance on 2007-10-23, under 510(k) number K072362.

Who is the listed applicant for NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG?

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

What is the FDA product code for NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG?

The FDA product code for NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG is DTZ.

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Other records listing Novalung GmbH as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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