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FDA 510(k)

MEDISONIC PNEU-NEB

K-Number: K896192 · 1990-01-03

ApplicantMedisonic U.S.A., Inc.
Decision Date1990-01-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISONIC PNEU-NEB 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 1990-01-03 under 510(k) number K896192. 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 PNEU-NEB?

MEDISONIC PNEU-NEB is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Medisonic U.S.A., Inc.. The 510(k) number is K896192.

When did MEDISONIC PNEU-NEB receive FDA 510(k) clearance?

MEDISONIC PNEU-NEB received FDA 510(k) clearance on 1990-01-03, under 510(k) number K896192.

Who is the listed applicant for MEDISONIC PNEU-NEB?

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 PNEU-NEB?

The FDA product code for MEDISONIC PNEU-NEB 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.

K924577MEDIVACK923660MEDISONIC OXYGEN FLOW CONTROLLERK901114MEDISONIC HUMDIFIER/INHALERK894961MEDISONIC ULTRA-SONIC INHALER

Related Devices (Code: CAF)

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Official Source

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