510(k) K830638

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

K830638 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "PHYSIOLOGICAL PRESSURE MEASUREMENT SYS". The FDA issued a decision of Substantially Equivalent on April 18, 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
April 18, 1983
Date Received
March 1, 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