FDA.report

510(k) K850898

Device
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER
Applicant
MEDI-TRACE PRODUCTS DIVISION
510(k) number
K850898
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-25
Date received
1985-03-04
Regulation
870.2850
Classification name
Transducer, Blood-pressure, Extravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ALBERT J AMELOTTE
Address
189 Van Rensselaer St. Buffalo NY US 14240 14240

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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Legacy Summary

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FDA Review

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