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 |