The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx820-5 Pressure Infusor 500cc Mx820-10.
| Device ID | K800560 |
| 510k Number | K800560 |
| Device Name: | MX820-5 PRESSURE INFUSOR 500CC MX820-10 |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | MEDEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-12 |
| Decision Date | 1980-04-29 |