The Virtual M-332
FDA 510(k) K960500 · Virtual Corp.
510(k) numberK960500
Submission
- Device name
- The Virtual M-332
- Applicant
- Virtual Corp.
Portland, OR, US - Received
- February 2, 1996
- Decision date
- April 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EWD – Protector, Hearing (Insert)
- Device class
- Unclassified
Other 510(k)s with product code EWD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020296 | Adult Silicone Ear Plugs, Models # 68053, 68057EWD · Traditional | Apothecary Products, Inc. | 06/25/2002SE |
| K972923 | Super Siliplugs Ear PlugsEWD · Traditional | Interview Medical Technology Corp. | 10/27/1997SE |
| K971517 | Silicone Putty Ear PlugsEWD · Traditional | Bentec Medical, Inc. | 06/02/1997SE |
| K962292 | HearsaverEWD · Traditional | Emtech Laboratories | 10/29/1996SE |
| K945376 | Doc's Proplugs Ear PlugsEWD · Traditional | Doc'S Proplugs, Inc. | 11/14/1995SE |
| K930203 | Model 322 Clinical AudiometerEWD · Traditional | Virtual Corp. | 07/08/1993SE |
| K915739 | #903 Silaflex IIEWD · Traditional | Flents Products Co., Inc. | 06/30/1992SE |
| K910177 | Seal-Rite Silicone Ear PlugEWD · Traditional | Flents Products Co., Inc. | 06/24/1991SE |
| K862045 | Doc's Proplugs Ear PlugsEWD · Traditional | Doc'S Proplugs, Inc. | 04/10/1987SE |
| K821187 | Medco Custom Ear Protector Mold KitEWD · Traditional | Santa Barbara Medco, Inc. | 05/27/1982SE |
More from Santa Barbara Medco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 The Virtual M-332 cleared by the FDA?
The Virtual M-332 (K960500) received a 510(k) decision of Substantially Equivalent on April 3, 1996, 61 days after the submission was received.
What is the product code of K960500?
The FDA product code is EWD – Protector, Hearing (Insert), a Unclassified device.