The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Medipart Remote Injection Sys For Ultravent Radioa.
| Device ID | K854550 |
| 510k Number | K854550 |
| Device Name: | MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Contact | Jerry Alexander |
| Correspondent | Jerry Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1985-12-19 |