The following data is part of a premarket notification filed by Virtual Corp. with the FDA for Model 330 Screening Audio Meter, Modified.
Device ID | K926574 |
510k Number | K926574 |
Device Name: | MODEL 330 SCREENING AUDIO METER, MODIFIED |
Classification | Stimulator, Auditory, Evoked Response |
Applicant | VIRTUAL CORP. 521 SW 11TH SUITE 400 Portland, OR 97205 |
Contact | Jonathan D Birck |
Correspondent | Jonathan D Birck VIRTUAL CORP. 521 SW 11TH SUITE 400 Portland, OR 97205 |
Product Code | GWJ |
CFR Regulation Number | 882.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-30 |
Decision Date | 1993-03-29 |