The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic Panomat Pump.
| Device ID | K915566 |
| 510k Number | K915566 |
| Device Name: | DISETRONIC PANOMAT PUMP |
| Classification | Pump, Infusion |
| Applicant | DISETRONIC MEDICAL SYSTEMS 8911 ABBOTSFORD TERRACE Fort Myers, FL 33912 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter DISETRONIC MEDICAL SYSTEMS 8911 ABBOTSFORD TERRACE Fort Myers, FL 33912 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-08-07 |