The following data is part of a premarket notification filed by Hirata Sangyo Co. Usa, Inc. with the FDA for Sr-model 230 (modification).
| Device ID | K864106 |
| 510k Number | K864106 |
| Device Name: | SR-MODEL 230 (MODIFICATION) |
| Classification | Pump, Infusion |
| Applicant | HIRATA SANGYO CO. USA, INC. 810 SOUTH SPRING ST., STE. 404 Los Angeles, CA 90014 |
| Contact | Karl C Bartel |
| Correspondent | Karl C Bartel HIRATA SANGYO CO. USA, INC. 810 SOUTH SPRING ST., STE. 404 Los Angeles, CA 90014 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1986-11-19 |