RATEMINDER(TM) V INFUSION PUMP, MODIFICATION

Pump, Infusion

CRITIKON COMPANY,LLC

The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Rateminder(tm) V Infusion Pump, Modification.

Pre-market Notification Details

Device IDK911769
510k NumberK911769
Device Name:RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
ClassificationPump, Infusion
Applicant CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa,  FL  33631 -3800
ContactJohn Matson
CorrespondentJohn Matson
CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa,  FL  33631 -3800
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-19
Decision Date1991-06-03

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