Tester, Auditory Impedance

Device Code: 1467

Product Code(s): ETY

Device Classification Information

• Device Type ID: 1467
• Device Name: Tester, Auditory Impedance
• Regulation Description: Auditory Impedance Tester.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(k)
• CFR Regulation Number: 874.1090 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: ETY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 4-90 ANSI S3.39:1987 (Reaffirmed 2012)
  American National Standard Specifications For Instruments To Measure Aural Acoustic Impedance And Admittance (Aural Acoustic Immittance)
• 4-160 ANSI S3.1 (Reaffirmed 2013)
  American National Standard Maximum Permissible Ambient Noise Levels For Audiometric Test Rooms
• 4-186 ANSI ASA S12.2-2008 (Revision Of ANSI S12.2-1995)
  American National Standard Criteria For Evaluating Room Noise
• 4-228 ANSI ASA S3.20-2015 (Revision Of ANSI S3.20-1995)
  American National Standard Bioacoustical Terminology

Total Product Life Cycle

• Device Type ID: 1467
• Device: Tester, Auditory Impedance
• Product Code: ETY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Auditory Impedance Tester.
• CFR Regulation Number: 874.1090 [🔎]

Premarket Reviews
Manufacturer	Decision
DB DIAGNOSTIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
GN OTOMETRICS A/S
	SUBSTANTIALLY EQUIVALENT	1
INTERACOUSTICS A/S
	SUBSTANTIALLY EQUIVALENT	1
INVENTIS SRL
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM DEMANT HOLDING A/S
	SUBSTANTIALLY EQUIVALENT	2

TPLC Last Update: 2019-04-02 19:54:32