The following data is part of a premarket notification filed by Vulcan Laboratories, Inc. with the FDA for Jee Frame (ventilator Circuit Support).
Device ID | K850924 |
510k Number | K850924 |
Device Name: | JEE FRAME (VENTILATOR CIRCUIT SUPPORT) |
Classification | Support, Breathing Tube |
Applicant | VULCAN LABORATORIES, INC. 8038 RUGBY AVE. Birmingham, AL 35206 |
Contact | Joe Emrico |
Correspondent | Joe Emrico VULCAN LABORATORIES, INC. 8038 RUGBY AVE. Birmingham, AL 35206 |
Product Code | JAY |
CFR Regulation Number | 868.5280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-05 |
Decision Date | 1985-07-19 |