The following data is part of a premarket notification filed by David Clark Company, Inc. with the FDA for Pressure Infuser.
| Device ID | K820159 |
| 510k Number | K820159 |
| Device Name: | PRESSURE INFUSER |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | DAVID CLARK COMPANY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-20 |
| Decision Date | 1982-04-21 |