Rexton Model 48 and 49PP
FDA 510(k) K970537 · Rexton, Inc.
510(k) numberK970537
Submission
- Device name
- Rexton Model 48 and 49PP
- Applicant
- Rexton, Inc.
Plymouth, MN, US - Received
- February 12, 1997
- Decision date
- March 28, 1997
- 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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|---|---|---|---|
| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| 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 |
| 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 |
|---|---|---|
| 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 |
| K954922 | Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale InstrumentsESD · Traditional | 01/17/1996SE |
| 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 Model 48 and 49PP cleared by the FDA?
Rexton Model 48 and 49PP (K970537) received a 510(k) decision of Substantially Equivalent on March 28, 1997, 44 days after the submission was received.
What is the product code of K970537?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.