The following data is part of a premarket notification filed by Hirata Sangyo Co. Usa, Inc. with the FDA for Sr- Model 230.
| Device ID | K842289 |
| 510k Number | K842289 |
| Device Name: | SR- MODEL 230 |
| Classification | Pump, Infusion |
| Applicant | HIRATA SANGYO CO. USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-08 |
| Decision Date | 1984-07-25 |