The following data is part of a premarket notification filed by Prime Medical Products, Inc. with the FDA for Prime Cadi-120.
| Device ID | K914148 |
| 510k Number | K914148 |
| Device Name: | PRIME CADI-120 |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | PRIME MEDICAL PRODUCTS, INC. 12472 PARK AVENUE Windermere, FL 34786 |
| Contact | Brian D Zdeb |
| Correspondent | Brian D Zdeb PRIME MEDICAL PRODUCTS, INC. 12472 PARK AVENUE Windermere, FL 34786 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-16 |
| Decision Date | 1992-10-05 |