The following data is part of a premarket notification filed by Virtual Corp. with the FDA for Model 340 Probe Mic System.
Device ID | K896301 |
510k Number | K896301 |
Device Name: | MODEL 340 PROBE MIC SYSTEM |
Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
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 | ETW |
CFR Regulation Number | 874.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1990-01-16 |