FDA.report

510(k) K981747

Device
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
Applicant
SUNSCOPE INTL., INC.
510(k) number
K981747
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
1998-08-20
Date received
1998-05-18
Regulation
870.2850
Classification name
Transducer, Blood-pressure, Extravascular
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
JOHN SHULZE
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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