The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Iv Admin. Set For Mvp 1 Infusion Pump.
Device ID | K843311 |
510k Number | K843311 |
Device Name: | IV ADMIN. SET FOR MVP 1 INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | ZIEHM INTERNATIONAL, INC. NY |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-23 |
Decision Date | 1985-03-13 |