The following data is part of a premarket notification filed by Imed Corp. with the FDA for Pressure Disc Component For Accuset.
| Device ID | K812824 |
| 510k Number | K812824 |
| Device Name: | PRESSURE DISC COMPONENT FOR ACCUSET |
| Classification | Pump, Infusion |
| Applicant | IMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-08 |
| Decision Date | 1981-10-27 |