The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mp0400 Adult, Peristalic Infusion Pump.
Device ID | K853814 |
510k Number | K853814 |
Device Name: | MP0400 ADULT, PERISTALIC INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Contact | Messinger |
Correspondent | Messinger MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-12 |
Decision Date | 1986-01-16 |