510(k) K926574
K926574 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 330 SCREENING AUDIO METER, MODIFIED". The FDA issued a decision of Substantially Equivalent on March 29, 1993. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Virtual Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1993
- Date Received
- December 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type