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510(k) K031148

Device
IN-VISION IMAGING SYSTEM
Applicant
Jomed, Inc.
510(k) number
K031148
Product code
DXK
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-28
Date received
2003-04-10
Regulation
870.2330
Classification name
Echocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LORRAINE W HUFFMAN
Address
2870 Kilgore Rd.. Rancho Cordova, CA US 95670 95670

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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