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FDA 510(k)

MICRON ONE PORTA. ULTRASONIC NEBULIZER

K-Number: K850926 · 1985-05-23

ApplicantEndotek Development Laboratories
Decision Date1985-05-23
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICRON ONE PORTA. ULTRASONIC NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Endotek Development Laboratories. It received FDA 510(k) clearance on 1985-05-23 under 510(k) number K850926. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRON ONE PORTA. ULTRASONIC NEBULIZER?

MICRON ONE PORTA. ULTRASONIC NEBULIZER is a medical device that received FDA 510(k) clearance on 1985-05-23. The listed applicant is Endotek Development Laboratories. The 510(k) number is K850926.

When did MICRON ONE PORTA. ULTRASONIC NEBULIZER receive FDA 510(k) clearance?

MICRON ONE PORTA. ULTRASONIC NEBULIZER received FDA 510(k) clearance on 1985-05-23, under 510(k) number K850926.

Who is the listed applicant for MICRON ONE PORTA. ULTRASONIC NEBULIZER?

The FDA 510(k) record lists Endotek Development Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRON ONE PORTA. ULTRASONIC NEBULIZER?

The FDA product code for MICRON ONE PORTA. ULTRASONIC NEBULIZER is CCQ.

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Related Devices (Code: CCQ)

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

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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