510(k) K832604

PHYSIOLOGICAL PRESSURE MEASUREMENT CATH by Camino Laboratories, Inc. — Product Code DXO

K832604 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "PHYSIOLOGICAL PRESSURE MEASUREMENT CATH". The FDA issued a decision of Substantially Equivalent on October 20, 1983. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1983
Date Received
August 3, 1983
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