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 |