AMERITEK SURE-POINT TRACKER SYSTEM

Transducer, Ultrasonic, Diagnostic

AMERTEK MEDICAL, INC.

The following data is part of a premarket notification filed by Amertek Medical, Inc. with the FDA for Ameritek Sure-point Tracker System.

Pre-market Notification Details

Device IDK030518
510k NumberK030518
Device Name:AMERITEK SURE-POINT TRACKER SYSTEM
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island,  FL  33404
ContactGreg Wiita
CorrespondentGreg Wiita
AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island,  FL  33404
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-19
Decision Date2003-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801741079177 K030518 000
00801741078897 K030518 000
00801741079054 K030518 000
00801741079061 K030518 000
00801741079092 K030518 000
00801741079108 K030518 000
00801741079122 K030518 000
00801741079139 K030518 000
00801741079146 K030518 000
00801741078880 K030518 000

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