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FDA 510(k)

Portable Nebulizer

K-Number: K170916 · 2017-11-28

Decision Date2017-11-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Microbase Technology Corporation. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K170916. 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 Portable Nebulizer?

Portable Nebulizer is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is Microbase Technology Corporation. The 510(k) number is K170916.

When did Portable Nebulizer receive FDA 510(k) clearance?

Portable Nebulizer received FDA 510(k) clearance on 2017-11-28, under 510(k) number K170916.

Who is the listed applicant for Portable Nebulizer?

The FDA 510(k) record lists Microbase Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Nebulizer?

The FDA product code for Portable Nebulizer is CAF.

Other records listing Microbase Technology Corporation 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.

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.

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.