510(k) K914765

SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS by Siemens Medical Electronics — Product Code DXN

K914765 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS". The FDA issued a decision of Substantially Equivalent on November 6, 1992. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
October 22, 1991
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