SELITHERM, MODEL C100

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

SELICOR, INC.

The following data is part of a premarket notification filed by Selicor, Inc. with the FDA for Selitherm, Model C100.

Pre-market Notification Details

Device IDK030382
510k NumberK030382
Device Name:SELITHERM, MODEL C100
ClassificationDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant SELICOR, INC. 7000 NORTH MOPAC, SECOND FLR. Austin,  TX  78731
ContactJames B Bingham
CorrespondentJames B Bingham
SELICOR, INC. 7000 NORTH MOPAC, SECOND FLR. Austin,  TX  78731
Product CodeIMJ  
CFR Regulation Number890.5290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-05
Decision Date2003-04-01

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