510(k) K051745

Device
ECHOSYSTEM
Applicant
MEDSTRAT, INC.
510(k) number
K051745
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2005-07-14
Date received
2005-06-29
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROBERT J BISHOP
Address
1901 Butterfield Rd. Suite 600 Downers Grove IL US 60515 60515

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

summary

FDA Review

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