Ma 610-IMPEDANCE Audiometer
FDA 510(k) K831754 · Maico Hearing Instruments, Inc.
510(k) numberK831754
Submission
- Device name
- Ma 610-IMPEDANCE Audiometer
- Applicant
- Maico Hearing Instruments, Inc.
Mchenry, IL, US - Received
- June 1, 1983
- Decision date
- July 7, 1983
- 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 |
|---|---|---|
| K960031 | Audioflex 120ESD · Traditional | 03/07/1996SE |
| K954054 | Maico Prodigy Cic SeriesESD · Traditional | 09/28/1995SE |
| K953161 | Maico MA630D Audiometer with Optional Reflex Decay & Eustachian Tube FunctionETY · Traditional | 07/24/1995SE |
| K950637 | Maico In-The-Ear Model RD-312 CicESD · Traditional | 03/21/1995SE |
| K946253 | Maico In-The-Ear Model RD 201ESD · Traditional | 01/30/1995SE |
| K931322 | KS 5 - Clinical AudiometerEWO · Traditional | 08/19/1994SE |
| K933291 | Maico Bte Model RD-111 and Ite Model RD-312 Hearing AidESD · Traditional | 08/23/1993SE |
| K930112 | Maico MA790 AudiometerEWO · Traditional | 08/05/1993SE |
| K926439 | MA25 - Portable Audiometer, ModificationEWO · Traditional | 08/05/1993SE |
| K931161 | Series Star 22 - Behind the Ear Hearing AidESD · Traditional | 06/01/1993SE |
Questions and answers
When was Ma 610-IMPEDANCE Audiometer cleared by the FDA?
Ma 610-IMPEDANCE Audiometer (K831754) received a 510(k) decision of Substantially Equivalent on July 7, 1983, 36 days after the submission was received.
What is the product code of K831754?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.