ULTRASOUND TRANSDUCER COVER

Transducer, Ultrasonic, Diagnostic

ADVANCE MEDICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Ultrasound Transducer Cover.

Pre-market Notification Details

Device IDK011265
510k NumberK011265
Device Name:ULTRASOUND TRANSDUCER COVER
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta,  GA  30066
ContactBill Gill
CorrespondentBill Gill
ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta,  GA  30066
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-25
Decision Date2001-10-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848340015257 K011265 000
10848340013765 K011265 000
10848340015165 K011265 000
10848340013642 K011265 000
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10848340015011 K011265 000
10848340015028 K011265 000
10848340014892 K011265 000

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