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FDA 510(k)

NASAL COMFORT FREEDOM

K-Number: K130686 · 2013-10-16

ApplicantLakeview Sleep Center
Decision Date2013-10-16
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASAL COMFORT FREEDOM is the device name listed in this FDA 510(k) record. The listed applicant is Lakeview Sleep Center. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K130686. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASAL COMFORT FREEDOM?

NASAL COMFORT FREEDOM is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is Lakeview Sleep Center. The 510(k) number is K130686.

When did NASAL COMFORT FREEDOM receive FDA 510(k) clearance?

NASAL COMFORT FREEDOM received FDA 510(k) clearance on 2013-10-16, under 510(k) number K130686.

Who is the listed applicant for NASAL COMFORT FREEDOM?

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

What is the FDA product code for NASAL COMFORT FREEDOM?

The FDA product code for NASAL COMFORT FREEDOM is BZD.

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Related Devices (Code: BZD)

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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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