TERATECH MODEL 10V5 SMART PROBE

Transducer, Ultrasonic, Diagnostic

TERATECH CORP.

The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Teratech Model 10v5 Smart Probe.

Pre-market Notification Details

Device IDK040840
510k NumberK040840
Device Name:TERATECH MODEL 10V5 SMART PROBE
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant TERATECH CORP. PO BOX 10074 13221 NE TEEM LOOP ROAD Bainbridge Island,  WA  98110
ContactCharles F Hottinger
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-04-01
Decision Date2004-04-14
Summary:summary

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