510(k) K961404

MX960 REUSABLE PRESSURE TRANSDUCER by Medex, Inc. — Product Code DRS

K961404 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MX960 REUSABLE PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on June 27, 1996. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1996
Date Received
April 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type