The following data is part of a premarket notification filed by Virtual Corp. with the FDA for Model 222 Clinical Audiometer.
Device ID | K934715 |
510k Number | K934715 |
Device Name: | MODEL 222 CLINICAL AUDIOMETER |
Classification | Audiometer |
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 | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-01 |
Decision Date | 1994-05-10 |