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56 Series Aerosol Generator

by Project Marketing

510(k) K980074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980074 Date12 Jun 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 56 Series Aerosol Generator is a device for the production of compressed air to operate a nebulizer for the production of medical aerosol. It is used in the context of respiratory disorders. The device generates aerosol, which is required for various applications. The 56 Series Aerosol Generator is classified under the product code CAF.

The 56 Series Aerosol Generator is supplied with an FDA 510K authorization, specifically K980074. The device is associated with the advisory committee for Anesthesiology. The authorization was granted after a 155-day FDA review. The device is intended to produce medical aerosol for respiratory disorders, and its specifications and clearance type are documented under the K980074 clearance.

Other devices from Project Marketing

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 56 Series Aerosol Generator used for?

    The 56 Series Aerosol Generator is designed to produce compressed air that operates a nebulizer for creating medical aerosol, specifically for treating respiratory disorders. It is classified under product code CAF.

  • How is the 56 Series Aerosol Generator supplied and what are its regulatory details?

    The device is supplied with FDA 510K authorization K980074, granted after a 155-day review. It is associated with the Anesthesiology advisory committee and is classified as substantially equivalent under traditional clearance.

  • Is the 56 Series Aerosol Generator reusable or single-use?

    The device data does not specify whether the 56 Series Aerosol Generator is designed for single-use or reuse. For proper handling and reuse instructions, please consult the manufacturer's documentation or contact Project Marketing directly.

  • What are the available sizes and models of the 56 Series Aerosol Generator?

    The device data does not provide information about different sizes or models of the 56 Series Aerosol Generator. For specific product variations, please contact Project Marketing or refer to their product catalog.