The following data is part of a premarket notification filed by Medix Medical Electronics (u.s.a.), Inc. with the FDA for Enternal Infuser Multipump 203.
Device ID | K861040 |
510k Number | K861040 |
Device Name: | ENTERNAL INFUSER MULTIPUMP 203 |
Classification | Pump, Infusion |
Applicant | MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. C/O WEINBERG-DORON & COMPANY 750 THIRD AVENUE New York, NY 10017 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-18 |
Decision Date | 1986-06-23 |