MC 300* Nebulizer

510(k) Number

K173367 ↗

FDA product code

CAF

Device class

Class II

Regulation

21 CFR Part 868.5630

Advisory committee

Anesthesiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

• DEVILBISS PULMO-AIDE COMPACT COMPRESSOR by Sunrise Medical
• DEVILBISS MODEL 8500D by The Devilbiss Co.
• U-MID PREFILLED NEBULIZER by Bd Becton Dickinson Vacutainer Systems Preanalytic
• MYSTIQUE ULTRASONIC NEBULIZER by Airsep Corp.
• Portable Nebulizer by MICROBASE TECHNOLOGY CORP.
• AERONEB GO NEBULIZER, MODEL AG-AG2000 by Aerogen, Inc.
• Propeller Sensor for Neohaler by Reciprocal Labs
• INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT by Intertech Resources, Inc.
• AERO-GEN NUBULIZER SYSTEM by Tri/Bor Medical, Inc.
• AERONEB SOLO; AERONEB SOLO ADAPTER by Aerogen Ltd

• RespiChamber

  Class I

  CE/MDR

• AeroChamber2go*

  Class I

  CE/MDD

• RespiChamber*

  Class I

  CE/MDR

• Aerochamber Plus Flow-Vu

  Class I

  CE/MDR

See all devices from Trudell Medical International →