The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Peristaltic Infusion Pump (2100,2101).
| Device ID | K760718 |
| 510k Number | K760718 |
| Device Name: | PERISTALTIC INFUSION PUMP (2100,2101) |
| Classification | Pump, Infusion |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 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 | 1976-09-25 |
| Decision Date | 1976-10-14 |