Prophet
FDA 510(k) K953884 · Qualitone
510(k) numberK953884
Submission
- Device name
- Prophet
- Applicant
- Qualitone
Minneapolis, MN, US - Received
- August 17, 1995
- Decision date
- October 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234095 | OtoNova/OtoNova ProEWO · Traditional | Otodynamics | 06/21/2024SE |
| K240430 | Otoport ProEWO · Special | Otodynamics, Ltd. | 03/15/2024SE |
| K231545 | hearOAEEWO · Traditional | Hearx SA (Pty) , Ltd. | 10/27/2023SE |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional | Path Medical GmbH | 06/22/2022SE |
| K191372 | LyraEWO · Traditional | Interacoustics A/S | 07/15/2019SE |
| 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 |
|---|---|---|
| K961827 | In-The-EarESD · Traditional | 07/03/1996SE |
| K955466 | Dynameq-Ii OptionESD · Traditional | 02/13/1996SE |
| K955359 | Cyber III Option Um, UC312, UC10, UcicESD · Traditional | 12/19/1995SE |
| K941107 | The Canal (C.I.C.) Aka/Hidden EarESD · Traditional | 08/09/1994SE |
| K935348 | Odyssey Clinical AudiometerEWO · Traditional | 02/09/1994SE |
| K935289 | Pro Fit-Cyber II OptionESD · Traditional | 12/22/1993SE |
| K923006 | AS-90ESD · Traditional | 09/18/1993SE |
| K923007 | AT-2EWO · Traditional | 02/26/1993SE |
| K923986 | Cybernetic Option (Cyber I)ESD · Traditional | 09/10/1992SE |
| K923013 | Acoustic Appraise CD-3EWO · Traditional | 08/14/1992SE |
Questions and answers
When was Prophet cleared by the FDA?
Prophet (K953884) received a 510(k) decision of Substantially Equivalent on October 27, 1995, 71 days after the submission was received.
What is the product code of K953884?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.