Model 210 Impedance System
FDA 510(k) K895443 · Virtual Corp.
510(k) numberK895443
Submission
- Device name
- Model 210 Impedance System
- Applicant
- Virtual Corp.
Portland, OR, US - Received
- September 8, 1989
- Decision date
- January 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
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More from Amplivox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K960500 | The Virtual M-332EWD · Traditional | 04/03/1996SE |
| K934715 | Model 222 Clinical AudiometerEWO · Traditional | 05/10/1994SE |
| K930203 | Model 322 Clinical AudiometerEWD · Traditional | 07/08/1993SE |
| K926574 | Model 330 Screening Audio Meter, ModifiedGWJ · Traditional | 03/29/1993SE |
| K911689 | Model 330 Screening AudiometerEWO · Traditional | 10/21/1991SE |
| K896301 | Model 340 Probe Mic SystemETW · Traditional | 01/16/1990SE |
| K863984 | Model 320 Two Channel AudiometerEWO · Traditional | 11/18/1986SE |
| K853863 | Model 310 Impedance SystemETY · Traditional | 12/18/1985SE |
Questions and answers
When was Model 210 Impedance System cleared by the FDA?
Model 210 Impedance System (K895443) received a 510(k) decision of Substantially Equivalent on January 16, 1990, 130 days after the submission was received.
What is the product code of K895443?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.