FDA.report

510(k) K100849

Device
SYNC-RX SYSTEM, MODEL AS00010
Applicant
SYNC-RX LTD
510(k) number
K100849
Product code
IZI  
Decision
Substantially Equivalent (SESE)
Decision date
2010-05-21
Date received
2010-03-26
Regulation
892.1600
Classification name
System, X-ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
A ANSELMO
Address
555 Zang St., Suite 100 Lakewood CO US 80228 80228

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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