510(k) K830687

NORELCO ELECTRONIC ANALOG BLOOD PRESS by North American Philips Corp. — Product Code DXN

K830687 is an FDA 510(k) premarket notification submitted by North American Philips Corp. for the device "NORELCO ELECTRONIC ANALOG BLOOD PRESS". The FDA issued a decision of Substantially Equivalent on May 18, 1983. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. North American Philips Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1983
Date Received
March 4, 1983
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