Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale Instruments
FDA 510(k) K954922 · Rexton, Inc.
510(k) numberK954922
Submission
- Device name
- Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale Instruments
- Applicant
- Rexton, Inc.
Plymouth, MN, US - Received
- October 26, 1995
- Decision date
- January 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| 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 |
More from Bernafon-Maico, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970537 | Rexton Model 48 and 49PPESD · Traditional | 03/28/1997SE |
| K964451 | Piccolo K-Amp Vc+, Piccolo P-A1, Piccolo P-Ao and Piccolo AtcESD · Traditional | 11/27/1996SE |
| K960295 | Long Life RX-12ESD · Traditional | 03/22/1996SE |
| K953770 | Rexton Mini-Primo Plus, PP142, D.C .H.I. FamilyESD · Traditional | 09/18/1995SE |
| K950451 | M-29 Pp-Pc, M-29 Pp-O/PcESD · Traditional | 03/21/1995SE |
| K944851 | Micro Mini Primo Agc, Micro-Mini Primo S-AgcESD · Traditional | 02/22/1995SE |
| K944777 | Orion PPM, PP, Pp-DESD · Traditional | 12/30/1994SE |
| K944359 | Expression RX-12, Enhancement RX-34, Elite RX-12ESD · Traditional | 12/29/1994SE |
| K942702 | Deep Canal Hearing InstrumentESD · Traditional | 12/21/1994SE |
| K944548 | Rexplus PP3ESD · Traditional | 11/14/1994SE |
Questions and answers
When was Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale Instruments cleared by the FDA?
Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale Instruments (K954922) received a 510(k) decision of Substantially Equivalent on January 17, 1996, 83 days after the submission was received.
What is the product code of K954922?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.