The following data is part of a premarket notification filed by Virtual Corp. with the FDA for Model 320 Two Channel Audiometer.
Device ID | K863984 |
510k Number | K863984 |
Device Name: | MODEL 320 TWO CHANNEL AUDIOMETER |
Classification | Audiometer |
Applicant | VIRTUAL CORP. P.O. BOX 8885 Portland, OR 97207 |
Contact | Jonathan D Birck |
Correspondent | Jonathan D Birck VIRTUAL CORP. P.O. BOX 8885 Portland, OR 97207 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-14 |
Decision Date | 1986-11-18 |