YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES

Catheter, Retention Type, Balloon

YSIS, INC

The following data is part of a premarket notification filed by Ysis, Inc with the FDA for Ysi Models 4400 Foley Catheter Temperature Probes.

Pre-market Notification Details

Device IDK921561
510k NumberK921561
Device Name:YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES
ClassificationCatheter, Retention Type, Balloon
Applicant YSIS, INC 1725 BRANNUM LN. Yellow Springs,  OH  45387 -0279
ContactFred Breidt
CorrespondentFred Breidt
YSIS, INC 1725 BRANNUM LN. Yellow Springs,  OH  45387 -0279
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-01
Decision Date1992-11-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884838008650 K921561 000
20884838006922 K921561 000
20884838006915 K921561 000
H29780010634160 K921561 000
H29780010634142 K921561 000
H29744682 K921561 000
H29744660 K921561 000
H29744642 K921561 000

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