Frequency Response Analyzer Computer Sys Cci-10

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K853320 ↗

FDA Product Code

ETW

Device Class

Class II

Regulation

21 CFR Part 874.3310

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Handtymp Screener Model 2000 + 2002 Remote Trans.

  Class II

  FDA 510(k) K890864 Active Cleared 21 Jun 1989

• Rastronics Cci 10/3 Hearing Aid Analysis

  Class II

  FDA 510(k) K902252 Active Cleared 12 Sep 1990

• Rastronics Portarem 20

  Class II

  FDA 510(k) K902287 Active Cleared 9 Aug 1990

• Rastronics Cci 8

  Class II

  FDA 510(k) K902244 Active Cleared 5 Oct 1990

• What is the Frequency Response Analyzer Computer System CCI-10 used for?

  The CCI-10 is designed to measure and analyze the frequency response characteristics of hearing aids and earphones, providing data for calibration and analysis purposes in Ear, Nose, and Throat applications.

• How is the Frequency Response Analyzer Computer System CCI-10 supplied?

  The device is supplied by Rastronics USA, Inc. as a complete computer system for frequency response analysis, though specific details about packaging or contents are not provided in the available data.

• Is the Frequency Response Analyzer Computer System CCI-10 single-use or reusable?

  The available data does not specify whether the CCI-10 is designed for single-use or multiple reuse. No information regarding sterility or MRI safety is provided in the device specifications.

• What is the regulatory status of the Frequency Response Analyzer Computer System CCI-10?

  The CCI-10 received FDA 510(k) clearance with number K853320 on September 27, 1985. It is classified as a Class II medical device under product code ETW and regulation number 874.3310 for Ear, Nose, and Throat applications.