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FDA 510(k)

MEDISONIC HUMDIFIER/INHALER

K-Number: K901114 · 1990-05-22

ApplicantMedisonic U.S.A., Inc.
Decision Date1990-05-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISONIC HUMDIFIER/INHALER is the device name listed in this FDA 510(k) record. The listed applicant is Medisonic U.S.A., Inc.. It received FDA 510(k) clearance on 1990-05-22 under 510(k) number K901114. 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 MEDISONIC HUMDIFIER/INHALER?

MEDISONIC HUMDIFIER/INHALER is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is Medisonic U.S.A., Inc.. The 510(k) number is K901114.

When did MEDISONIC HUMDIFIER/INHALER receive FDA 510(k) clearance?

MEDISONIC HUMDIFIER/INHALER received FDA 510(k) clearance on 1990-05-22, under 510(k) number K901114.

Who is the listed applicant for MEDISONIC HUMDIFIER/INHALER?

The FDA 510(k) record lists Medisonic U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISONIC HUMDIFIER/INHALER?

The FDA product code for MEDISONIC HUMDIFIER/INHALER is CAF.

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Other records listing Medisonic U.S.A., Inc. 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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Related Devices (Code: CAF)

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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