THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS

Pump, Infusion

IMED CORP.

The following data is part of a premarket notification filed by Imed Corp. with the FDA for The Imed Orion Infusion Pump And Administration Sets.

Pre-market Notification Details

Device IDK950419
510k NumberK950419
Device Name:THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
ClassificationPump, Infusion
Applicant IMED CORP. 9775 BUSINESSPARK AVE. San Diego,  CA  92131 -1699
ContactAhmad Sajadi
CorrespondentAhmad Sajadi
IMED CORP. 9775 BUSINESSPARK AVE. San Diego,  CA  92131 -1699
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-31
Decision Date1995-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50885403245419 K950419 000
37613203019232 K950419 000
10885403810015 K950419 000
10885403222054 K950419 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.