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FDA 510(k)

DELUXE NEBULIZER

K-Number: K063449 · 2007-03-01

ApplicantAccess Point Medical, LLC
Decision Date2007-03-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DELUXE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Access Point Medical, LLC. It received FDA 510(k) clearance on 2007-03-01 under 510(k) number K063449. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELUXE NEBULIZER?

DELUXE NEBULIZER is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is Access Point Medical, LLC. The 510(k) number is K063449.

When did DELUXE NEBULIZER receive FDA 510(k) clearance?

DELUXE NEBULIZER received FDA 510(k) clearance on 2007-03-01, under 510(k) number K063449.

Who is the listed applicant for DELUXE NEBULIZER?

The FDA 510(k) record lists Access Point Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELUXE NEBULIZER?

The FDA product code for DELUXE NEBULIZER is CAF.

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Other records listing Access Point Medical, LLC as applicant

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Related Devices (Code: CAF)

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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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