The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Venshield.
Device ID | K941813 |
510k Number | K941813 |
Device Name: | VENSHIELD |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | CYBERMEDIC, INC. 6175 B LONGBOW DR. Boulder, CO 80301 |
Contact | Bonnie Norman |
Correspondent | Bonnie Norman CYBERMEDIC, INC. 6175 B LONGBOW DR. Boulder, CO 80301 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-12 |
Decision Date | 1994-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VENSHIELD 74590249 2012497 Dead/Cancelled |
RELA, Inc. 1994-10-25 |