Aero-Mist Nebulizer

FDA 510(k) K881812 · Cadema Medical Products, Inc.

Substantially Equivalent

510(k) numberK881812

Submission

Device name
Aero-Mist Nebulizer
Applicant
Cadema Medical Products, Inc.
Middletown, NY, US
Received
April 28, 1988
Decision date
July 18, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYT – System, Rebreathing, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1390
Specialty
Radiology

Other 510(k)s with product code IYT

510(k)DeviceApplicantDecision
K253942Pulmonex II Xenon System (132-503)IYT · Traditional Mirion Technologies (Capintec), Inc.07/07/2026SE
K200916Patient Administration SetIYT · Traditional Cyclomedica Australia Pty, Ltd.09/01/2020SE
K953513Xenon CircuitIYT · Traditional King Systems Corp.11/03/1995SE
K952223Xenon Gas Breathing CircuitIYT · Traditional Intertech Resources, Inc.08/11/1995SE
K914747Xenon CircuitIYT · Traditional Gibeck, Inc.02/27/1992SE
K913416Tetley Patient Administration SetIYT · Traditional Tetley Medical , Ltd.10/28/1991SE
K912626Bolus Xenon CircuitIYT · Traditional Vital Signs, Inc.08/02/1991SE
K904684Amici Krypton Administration System, ModificationIYT · Traditional Amici, Inc.01/14/1991SE
K903805Amici Xenon Administration SetIYT · Traditional Amici, Inc.01/14/1991SE
K903694Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional Amici, Inc.10/03/1990SE

More from Amici, Inc.

510(k)DeviceDecision
K901476Modified Entrapping FilterCAH · Traditional 05/01/1990SE
K896773Disposable Face MaskBYG · Traditional 01/12/1990SE
K896116Entrapping FilterCAH · Traditional 11/17/1989SE
K873930Aerosol Delivery System (Aero-Tech II)CAF · Traditional 12/07/1987SE
K800023Lung Aerosol UnitCAF · Traditional 01/01/1985SE

Questions and answers

When was Aero-Mist Nebulizer cleared by the FDA?

Aero-Mist Nebulizer (K881812) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 81 days after the submission was received.

What is the product code of K881812?

The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.