FDA.report

510(k) K022004

Device
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
Applicant
BIOSENSORS INTERNATIONAL-USA
510(k) number
K022004
Product code
DQO  
Decision
Substantially Equivalent (SESE)
Decision date
2003-03-12
Date received
2002-06-19
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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
JORGE HAIDER
Address
20250 Acacia St., Suite 115 Newport Beach CA US 92660 92660

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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