FDA.report

510(k) K101669

Device
THERMODILUTION CATHETER
Applicant
BIOSENSORS INTL. PTE. LTD.
510(k) number
K101669
Product code
DQO  
Decision
Substantially Equivalent (SESE)
Decision date
2010-07-01
Date received
2010-06-14
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MOSES THAM
Address
21 Kallang Ave. #07-165/ 171 Singapore SG 339412 339412

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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