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FDA 510(k)

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104

K-Number: K102483 · 2011-09-13

ApplicantSunset Healthcare Solutions, LLC
Decision Date2011-09-13
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 is the device name listed in this FDA 510(k) record. The listed applicant is Sunset Healthcare Solutions, LLC. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K102483. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104?

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is Sunset Healthcare Solutions, LLC. The 510(k) number is K102483.

When did SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 receive FDA 510(k) clearance?

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 received FDA 510(k) clearance on 2011-09-13, under 510(k) number K102483.

Who is the listed applicant for SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104?

The FDA 510(k) record lists Sunset Healthcare Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104?

The FDA product code for SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 is CAH.

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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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