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FDA 510(k)

NARVAL CC

K-Number: K113201 · 2011-12-01

ApplicantResmed Sas
Decision Date2011-12-01
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NARVAL CC is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Sas. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K113201. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NARVAL CC?

NARVAL CC is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Resmed Sas. The 510(k) number is K113201.

When did NARVAL CC receive FDA 510(k) clearance?

NARVAL CC received FDA 510(k) clearance on 2011-12-01, under 510(k) number K113201.

Who is the listed applicant for NARVAL CC?

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

What is the FDA product code for NARVAL CC?

The FDA product code for NARVAL CC is LQZ.

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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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