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FDA 510(k)

FUNHALER, MODEL FH 101

K-Number: K042546 · 2005-01-03

ApplicantInfamed , Ltd.
Decision Date2005-01-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FUNHALER, MODEL FH 101 is the device name listed in this FDA 510(k) record. The listed applicant is Infamed , Ltd.. It received FDA 510(k) clearance on 2005-01-03 under 510(k) number K042546. 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 FUNHALER, MODEL FH 101?

FUNHALER, MODEL FH 101 is a medical device that received FDA 510(k) clearance on 2005-01-03. The listed applicant is Infamed , Ltd.. The 510(k) number is K042546.

When did FUNHALER, MODEL FH 101 receive FDA 510(k) clearance?

FUNHALER, MODEL FH 101 received FDA 510(k) clearance on 2005-01-03, under 510(k) number K042546.

Who is the listed applicant for FUNHALER, MODEL FH 101?

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

What is the FDA product code for FUNHALER, MODEL FH 101?

The FDA product code for FUNHALER, MODEL FH 101 is CAF.

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Other records listing Infamed , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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