UP800 a Universal Printer
FDA 510(k) K845050 · Madsen Electronics (Canada) , Ltd.
510(k) numberK845050
Submission
- Device name
- UP800 a Universal Printer
- Applicant
- Madsen Electronics (Canada) , Ltd.
Oakville, Ontario, CA - Received
- November 26, 1984
- Decision date
- May 29, 1985
- 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
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|---|---|---|---|
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| 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 |
|---|---|---|
| K942749 | Hi-Pro/Noah Universal Hearing InstrumentESD · Traditional | 07/18/1994SE |
| K931325 | Otoacoustic Emissions Unit Celesta 503EWO · Traditional | 02/18/1994SE |
| K931324 | Orbiter 922 Clinical AudiometerEWO · Traditional | 11/19/1993SE |
| K910247 | Zodiac 901 Middle-Ear AnalyzerETY · Traditional | 06/19/1991SE |
| K884372 | Madsen IGO1500 Insertion Gain OptimizerETW · Traditional | 02/13/1989SE |
| K884371 | Madsen IGO-HAT1500 Hearing Aid Dispenser SystemETW · Traditional | 02/13/1989SE |
| K883478 | Diagnostic Audiometer, Model Midimate 602EWO · Traditional | 11/17/1988SE |
| K874354 | Audiometric Impedance Tester, Model Z02020ETY · Traditional | 01/27/1988SE |
| K870229 | Hearing Aid Test System Model Hat 1000ETW · Traditional | 03/13/1987SE |
| K861905 | Plotter Model (MP100) · Traditional | 11/26/1986SE |
Questions and answers
When was UP800 a Universal Printer cleared by the FDA?
UP800 a Universal Printer (K845050) received a 510(k) decision of Substantially Equivalent on May 29, 1985, 184 days after the submission was received.
What is the product code of K845050?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.