510(k) K894033

DISPOSABLE CATHETER PRESSURE TRANSDUCER by Deseret Medical, Inc. — Product Code DXO

K894033 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "DISPOSABLE CATHETER PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1989
Date Received
June 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type