BP-SPECT V1.O

System, Tomography, Computed, Emission

SYNTERMED, INC.

The following data is part of a premarket notification filed by Syntermed, Inc. with the FDA for Bp-spect V1.o.

Pre-market Notification Details

Device IDK042258
510k NumberK042258
Device Name:BP-SPECT V1.O
ClassificationSystem, Tomography, Computed, Emission
Applicant SYNTERMED, INC. 245 OWENS DR. Anaheim,  CA  92808
ContactKenneth F Van Train
CorrespondentKenneth F Van Train
SYNTERMED, INC. 245 OWENS DR. Anaheim,  CA  92808
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-20
Decision Date2004-10-04
Summary:summary

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