The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic D-modem.
Device ID | K961975 |
510k Number | K961975 |
Device Name: | DISETRONIC D-MODEM |
Classification | Pump, Infusion |
Applicant | DISETRONIC MEDICAL SYSTEMS 32 HEMLOCK ST. Londonderry, NH 03053 -3750 |
Contact | Walter Piskorski |
Correspondent | Walter Piskorski DISETRONIC MEDICAL SYSTEMS 32 HEMLOCK ST. Londonderry, NH 03053 -3750 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-20 |
Decision Date | 1997-01-30 |
Summary: | summary |