Model 330 Screening Audio Meter, Modified
FDA 510(k) K926574 · Virtual Corp.
510(k) numberK926574
Submission
- Device name
- Model 330 Screening Audio Meter, Modified
- Applicant
- Virtual Corp.
Portland, OR, US - Received
- December 30, 1992
- Decision date
- March 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Gn Otometrics
| 510(k) | Device | Decision |
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| 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 |
| K911689 | Model 330 Screening AudiometerEWO · Traditional | 10/21/1991SE |
| K896301 | Model 340 Probe Mic SystemETW · Traditional | 01/16/1990SE |
| K895443 | Model 210 Impedance SystemETY · 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 330 Screening Audio Meter, Modified cleared by the FDA?
Model 330 Screening Audio Meter, Modified (K926574) received a 510(k) decision of Substantially Equivalent on March 29, 1993, 89 days after the submission was received.
What is the product code of K926574?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.