CAS (Computerized Analyzer System)

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K896996 ↗

FDA Product Code

ETW

Device Class

Class II

Regulation

21 CFR Part 874.3310

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Danavox Models 163/162 Bte

  Class I

  FDA 510(k) K971032 Active Cleared 17 Jun 1997

• Audallion III Hearing System

  Class I

  FDA 510(k) K971031 Active Cleared 17 Jun 1997

• 143 Series Bte

  Class I

  FDA 510(k) K905692 Active Cleared 28 Jan 1991

• Danavox Model Cic

  Class I

  FDA 510(k) K942331 Active Cleared 15 Nov 1994

• Custom in-the-Ear

  Class I

  FDA 510(k) K863975 Active Cleared 7 Nov 1986

• Dfs Genius Bte

  Class I

  FDA 510(k) K924185 Active Cleared 3 Nov 1992

See all devices from Gn Danavox, Inc. →

• What is the CAS Computerized Analyzer System used for?

  The CAS is a device designed to evaluate and calibrate hearing aids and earphones to ensure proper functioning and performance. It helps verify that audio devices meet their intended specifications before use by patients.

• Is the CAS system sterile and how is it supplied?

  The CAS is supplied as a non-sterile device and is intended for multiple uses. It should be handled according to standard laboratory equipment protocols and stored according to the manufacturer's instructions.

• What are the regulatory specifications for the CAS system?

  The CAS has FDA 510K clearance with product code ETW and is classified under Ear, Nose, and Throat medical specialty. It received clearance in 1990 and is not MRI compatible.

• How is the CAS system classified in terms of device class?

  The CAS is classified as a Class 2 medical device under the FDA's classification system. This classification indicates that it is a device with moderate risk to patients and requires special controls to ensure its safety and effectiveness.