510(k) K874917

PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM by Oxford Medilog, Inc. — Product Code DXN

K874917 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 10, 1988. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1988
Date Received
December 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type