FDA.report

510(k) K070710

Device
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
Applicant
BIOSENSORS INTERNATIONAL-USA
510(k) number
K070710
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
2007-04-19
Date received
2007-03-14
Regulation
870.2850
Classification name
Transducer, Blood-pressure, Extravascular
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
Sara Toyloy
Address
20280 Acacia St., Suite 300 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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