IntelligentVRA Software M815000

• FDA 510(k) K900096 decided 31 May 1990 Active
• FDA GUDID UDI-DI 00817020020884 listed 24 Sep 2016 Listed

1. 31 May 1990 Cleared FDA 510(k) K900096
2. 24 Sep 2016 Listed FDA GUDID 00817020020884

Trade name

IntelligentVRA Software

Generic name

Visual-reinforcement audiometer

Model / reference

M815000

Primary DI / UDI-DI

00817020020884

510(k) Number

K900096 ↗

FDA product code

EWO

GMDN term

Visual-reinforcement audiometer

Device class

Class II

Regulation number

874.1050

GUDID distribution status

In Commercial Distribution

Category: Visual-reinforcement audiometer

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• CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT by ETYMOTIC RESEARCH, INC.
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• COMPUTER AUDIOMETER - MA25 by Maico Hearing Instruments, Inc.
• INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER by Idem (Int'L Dist. of Electronics For Medicine)

• Capella2 OAE Start-Up Kit 8-69-42800

  Class II

  FDA 510(k) K061443 Active Cleared 23 Jun 2006 GUDID on market

• SEP StartUp Kit - 1 Channel M019200

  Class II

  FDA 510(k) ×3 Active Cleared 18 Jul 2007 GUDID on market

• SEP StartUp Kit - 2 Channels M019201

  Class II

  FDA 510(k) ×3 Active Cleared 18 Jul 2007 GUDID on market

• SEP StartUp Kit - 4 Channels M019202

  Class II

  FDA 510(k) ×3 Active Cleared 18 Jul 2007 GUDID on market

See all devices from Intelligent Hearing Systems Corp. →