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FDA 510(k)

DISPOSABLE HAND HELD NEBULIZER

K-Number: K800562 · 1980-03-25

ApplicantIntec Medical, Inc.
Decision Date1980-03-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HAND HELD NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800562. 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 DISPOSABLE HAND HELD NEBULIZER?

DISPOSABLE HAND HELD NEBULIZER is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Intec Medical, Inc.. The 510(k) number is K800562.

When did DISPOSABLE HAND HELD NEBULIZER receive FDA 510(k) clearance?

DISPOSABLE HAND HELD NEBULIZER received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800562.

Who is the listed applicant for DISPOSABLE HAND HELD NEBULIZER?

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

What is the FDA product code for DISPOSABLE HAND HELD NEBULIZER?

The FDA product code for DISPOSABLE HAND HELD NEBULIZER is CAF.

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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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