Resound Portable Prescriptive Programming System
FDA 510(k) K912669 · Resound Corp.
510(k) numberK912669
Submission
- Device name
- Resound Portable Prescriptive Programming System
- Applicant
- Resound Corp.
Redwood City, CA, US - Received
- June 18, 1991
- Decision date
- September 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
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| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional | Path Medical GmbH | 06/22/2022SE |
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| K180287 | GSI CortiEWO · Traditional | Grason-Stadler, Inc. | 05/11/2018SE |
| K173567 | SeraEWO · Traditional | Interacoustics A/S | 02/14/2018SE |
| K172403 | GSI NovusEWO · Traditional | Grason-Stadler, Inc. | 10/20/2017SE |
| K171506 | EasyscreenEWO · Traditional | Maico Diagnostics GmbH | 08/29/2017SE |
| K151025 | iHearTestEWO · Traditional | Ihear Medical, Inc. | 12/29/2015SE |
More from Ihear Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984547 | Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsEWO · Traditional | 03/19/1999SE |
| K974257 | Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer)ESD · Traditional | 12/12/1997SE |
| K974081 | Resound Stealth CicESD · Traditional | 12/12/1997SE |
| K971605 | Resound ED4 Personal Hearing System W/Remote Control OptionESD · Traditional | 07/03/1997SE |
| K970215 | Audallion II Hearing SystemESD · Traditional | 03/31/1997SE |
| K964557 | Resound BT4 Personal Hearing System W/Remote Control OptionESD · Traditional | 11/27/1996SE |
| K964115 | Resound CC4 Personal Hearing SystemESD · Traditional | 11/04/1996SE |
| K960684 | Hearing Aid - Air ConductionESD · Traditional | 04/10/1996SE |
| K960680 | Resound Personal Hearing Systems Edr Encore Series Models Edr-E, Edr-Es, Edr-Ev, & EDR-P1ESD · Traditional | 04/10/1996SE |
| K960052 | Resound Personal Hearing System BT2-ES, BT2-EV, & BT241ESD · Traditional | 03/12/1996SE |
Questions and answers
When was Resound Portable Prescriptive Programming System cleared by the FDA?
Resound Portable Prescriptive Programming System (K912669) received a 510(k) decision of Substantially Equivalent on September 16, 1991, 90 days after the submission was received.
What is the product code of K912669?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.