The following data is part of a premarket notification filed by Virtual Corp. with the FDA for Model 310 Impedance System.
Device ID | K853863 |
510k Number | K853863 |
Device Name: | MODEL 310 IMPEDANCE SYSTEM |
Classification | Tester, Auditory Impedance |
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 | ETY |
CFR Regulation Number | 874.1090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-17 |
Decision Date | 1985-12-18 |