GERATHERM UNIQUERESC

System, Thermal Regulating

GERATHERM MEDICAL AG

The following data is part of a premarket notification filed by Geratherm Medical Ag with the FDA for Geratherm Uniqueresc.

Pre-market Notification Details

Device IDK093694
510k NumberK093694
Device Name:GERATHERM UNIQUERESC
ClassificationSystem, Thermal Regulating
Applicant GERATHERM MEDICAL AG SCHWARZWALDSTRASSE 5 Tuttligen,  DE 78532
ContactAndrea Pecsi
CorrespondentAndrea Pecsi
GERATHERM MEDICAL AG SCHWARZWALDSTRASSE 5 Tuttligen,  DE 78532
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-30
Decision Date2010-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00614801001502 K093694 000
00614801001304 K093694 000

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