BW685, BW685S

Warmer, Thermal, Infusion Fluid

BIEGLER GMBH

The following data is part of a premarket notification filed by Biegler Gmbh with the FDA for Bw685, Bw685s.

Pre-market Notification Details

Device IDK121198
510k NumberK121198
Device Name:BW685, BW685S
ClassificationWarmer, Thermal, Infusion Fluid
Applicant BIEGLER GMBH 24301 WOODSAGE DR Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
BIEGLER GMBH 24301 WOODSAGE DR Bonita Springs,  FL  34134
Product CodeLGZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-19
Decision Date2012-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09008247000501 K121198 000
19008247000843 K121198 000
19008247000249 K121198 000
19008247000232 K121198 000

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