510(k) K842486

ELECTRONIC DIGITAL BP METER HC 3001 by North American Philips Corp. — Product Code DXN

K842486 is an FDA 510(k) premarket notification submitted by North American Philips Corp. for the device "ELECTRONIC DIGITAL BP METER HC 3001". The FDA issued a decision of Substantially Equivalent on August 24, 1984. 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
August 24, 1984
Date Received
June 26, 1984
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