MODEL AR-6300 INFUSION PUMP

Arthroscope

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Model Ar-6300 Infusion Pump.

Pre-market Notification Details

Device IDK915721
510k NumberK915721
Device Name:MODEL AR-6300 INFUSION PUMP
ClassificationArthroscope
Applicant ARTHREX, INC. 1963 ROCK ST. SUITE17 Mountain View,  CA  94043
ContactCharles L Rose
CorrespondentCharles L Rose
ARTHREX, INC. 1963 ROCK ST. SUITE17 Mountain View,  CA  94043
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-20
Decision Date1992-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888867039336 K915721 000

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