510(k) K864320

SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE by Cordis Corp. — Product Code DRQ

K864320 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1987
Date Received
November 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type