510(k) K811636

NORELCO ELECTRONIC BLOOD PRESSURE METER by North American Philips Corp. — Product Code DXN

K811636 is an FDA 510(k) premarket notification submitted by North American Philips Corp. for the device "NORELCO ELECTRONIC BLOOD PRESSURE METER". The FDA issued a decision of Substantially Equivalent on June 30, 1981. 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
June 30, 1981
Date Received
June 10, 1981
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