FDA.report

510(k) K100468

Device
ZEISS INFRARED 800 WITH FLOW 800 OPTION
Applicant
CARL ZEISS SURGICAL GMBH
510(k) number
K100468
Product code
IZI  
Decision
Substantially Equivalent (SESE)
Decision date
2010-03-03
Date received
2010-02-18
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
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JUDITH BRIMACOMBE
Address
5160 Hacienda Dr. Dublin CA US 94568 94568

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
04049539070128INFRARED 800 with FLOW® 800 OptionCarl Zeiss Meditec AG2017-04-24
04049539102362INFRARED 800 with FLOW® 800 OptionCarl Zeiss Meditec AG2016-09-23

Legacy Summary

summary

FDA Review

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