FDA.report

510(k) K983372

Device
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
Applicant
SUNSCOPE INTL., INC.
510(k) number
K983372
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-05
Date received
1998-09-24
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
PHIL TRIOLO
Address
148 So. 1200 E. Salt Lake City UT US 84102 84102

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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