Personal Amplifier Rechargeable Model Triumph II
FDA 510(k) K893432 · Electone, Inc.
510(k) numberK893432
Submission
- Device name
- Personal Amplifier Rechargeable Model Triumph II
- Applicant
- Electone, Inc.
Winter Park, FL, US - Received
- May 2, 1989
- Decision date
- August 4, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
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| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
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| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
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| K955702 | Sonata U-01ESD · Traditional | 02/22/1996SE |
| K953050 | Z33ESD · Traditional | 08/22/1995SE |
| K953047 | Z20ESD · Traditional | 08/22/1995SE |
| K953054 | Am 260 OhmESD · Traditional | 08/15/1995SE |
| K953053 | Am 260 PPESD · Traditional | 08/15/1995SE |
| K953052 | Am 260 K-AmpESD · Traditional | 08/15/1995SE |
| K953051 | Z35ESD · Traditional | 08/15/1995SE |
| K953049 | Z24ESD · Traditional | 08/15/1995SE |
Questions and answers
When was Personal Amplifier Rechargeable Model Triumph II cleared by the FDA?
Personal Amplifier Rechargeable Model Triumph II (K893432) received a 510(k) decision of Substantially Equivalent on August 4, 1989, 94 days after the submission was received.
What is the product code of K893432?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.