FDA.report

510(k) K920977

Device
MERITRANS(TM) DISPOSABLE TRANSDUCER
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K920977
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-11
Date received
1992-03-02
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
DENNIS REIGLE
Address
79 W. 4500 S., Suite 9 Salt Lake City UT US 84107 84107

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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