Preamplifier Models 8101PI & 8102PI
FDA 510(k) K781474 · Life-Tech Instruments, Inc.
510(k) numberK781474
Submission
- Device name
- Preamplifier Models 8101PI & 8102PI
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- August 28, 1978
- Decision date
- September 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K812177 | Life-Tech #1857 Pressure/Polot ModuleEXQ · Traditional | 09/09/1981SE |
| K812179 | Life-Tech #1753 Biofeedback TrainerHCC · Traditional | 08/25/1981SE |
| K812180 | Life-Tech #5102 VisulabGWN · Traditional | 08/21/1981SE |
| K812178 | Life-Tech #'S 1106/1156 UrolabsFAP · Traditional | 08/13/1981SE |
| K800112 | Amblyopia TrainerHPL · Traditional | 03/10/1980SE |
| K790663 | Model 1750 Standing UrinalFFG · Traditional | 04/24/1979SE |
| K790664 | Model 1309 Audio MonitorIKN · Traditional | 04/23/1979SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | 11/15/1978SE |
| K781461 | Model 7320 Visual StimulatorGWE · Traditional | 11/08/1978SE |
| K781475 | Electrode Impedance Tester-Model 500GYA · Traditional | 09/07/1978SE |
Questions and answers
When was Preamplifier Models 8101PI & 8102PI cleared by the FDA?
Preamplifier Models 8101PI & 8102PI (K781474) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 10 days after the submission was received.
What is the product code of K781474?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.