Z0174, Impedance Audiometer
FDA 510(k) K845049 · Madsen Electronics (Canada) , Ltd.
510(k) numberK845049
Submission
- Device name
- Z0174, Impedance Audiometer
- Applicant
- Madsen Electronics (Canada) , Ltd.
Oakville, Ontario, CA - Received
- November 26, 1984
- Decision date
- May 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
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More from Amplivox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K942749 | Hi-Pro/Noah Universal Hearing InstrumentESD · Traditional | 07/18/1994SE |
| K931325 | Otoacoustic Emissions Unit Celesta 503EWO · Traditional | 02/18/1994SE |
| K931324 | Orbiter 922 Clinical AudiometerEWO · Traditional | 11/19/1993SE |
| K910247 | Zodiac 901 Middle-Ear AnalyzerETY · Traditional | 06/19/1991SE |
| K884372 | Madsen IGO1500 Insertion Gain OptimizerETW · Traditional | 02/13/1989SE |
| K884371 | Madsen IGO-HAT1500 Hearing Aid Dispenser SystemETW · Traditional | 02/13/1989SE |
| K883478 | Diagnostic Audiometer, Model Midimate 602EWO · Traditional | 11/17/1988SE |
| K874354 | Audiometric Impedance Tester, Model Z02020ETY · Traditional | 01/27/1988SE |
| K870229 | Hearing Aid Test System Model Hat 1000ETW · Traditional | 03/13/1987SE |
| K861905 | Plotter Model (MP100) · Traditional | 11/26/1986SE |
Questions and answers
When was Z0174, Impedance Audiometer cleared by the FDA?
Z0174, Impedance Audiometer (K845049) received a 510(k) decision of Substantially Equivalent on May 21, 1985, 176 days after the submission was received.
What is the product code of K845049?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.