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FDA 510(k)

AEROMIST LT, MODEL HCS15004

K-Number: K031686 · 2004-01-21

ApplicantMedline Industries, Inc.
Decision Date2004-01-21
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROMIST LT, MODEL HCS15004 is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2004-01-21 under 510(k) number K031686. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROMIST LT, MODEL HCS15004?

AEROMIST LT, MODEL HCS15004 is a medical device that received FDA 510(k) clearance on 2004-01-21. The listed applicant is Medline Industries, Inc.. The 510(k) number is K031686.

When did AEROMIST LT, MODEL HCS15004 receive FDA 510(k) clearance?

AEROMIST LT, MODEL HCS15004 received FDA 510(k) clearance on 2004-01-21, under 510(k) number K031686.

Who is the listed applicant for AEROMIST LT, MODEL HCS15004?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEROMIST LT, MODEL HCS15004?

The FDA product code for AEROMIST LT, MODEL HCS15004 is BTI.

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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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