AUTOMATIC PERITONEAL DIALYSIS CYCLER

System, Peritoneal, Automatic Delivery

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Automatic Peritoneal Dialysis Cycler.

Pre-market Notification Details

Device IDK833065
510k NumberK833065
Device Name:AUTOMATIC PERITONEAL DIALYSIS CYCLER
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-08
Decision Date1983-11-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412030550 K833065 000
50085412007675 K833065 000

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