Microtek Medical's Sound Stiks
FDA 510(k) K913276 · Microbio-Medics, Inc.
510(k) numberK913276
Submission
- Device name
- Microtek Medical's Sound Stiks
- Applicant
- Microbio-Medics, Inc.
Memphis, TN, US - Received
- July 23, 1991
- Decision date
- October 21, 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
Other 510(k)s with product code EWO
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| 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 |
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|---|---|---|
| K923353 | Ventilation Tubes W/ Hydrogel CoatingETD · Traditional | 05/18/1993SE |
| K922572 | 321Q Minimum Energy Tinnitus SuppressorKLW · Traditional | 11/02/1992SE |
| K904239 | Soft Hydroxylapatite Ossicular Malleable ProsthesETA · Traditional | 06/21/1991SE |
| K910167 | Microtek-Heritages Silicone Bulb Evacuation SystemGCY · Traditional | 04/15/1991SE |
| K900726 | Microtek Medical's Blood Collection KitJKA · Traditional | 05/04/1990SE |
| K901154 | Microtek's Surgical Lamp Handle & CoverFTA · Traditional | 03/20/1990SE |
| K895815 | Microtek Total Ossicular ProthesisETA · Traditional | 12/26/1989SE |
| K895814 | Microtek Piston & Wire ProsthesesETB · Traditional | 12/26/1989SE |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal SplintEPP · Traditional | 12/08/1989SE |
| K885201 | Ossicular Prostheses 4 Partial, 4 Total, 2 ConvertETA · Traditional | 04/19/1989SE |
Questions and answers
When was Microtek Medical's Sound Stiks cleared by the FDA?
Microtek Medical's Sound Stiks (K913276) received a 510(k) decision of Substantially Equivalent on October 21, 1991, 90 days after the submission was received.
What is the product code of K913276?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.