510(k) K832171

SELF CHECK DIGITAL BLOOD PRESS. MONITOR by Ritter Co. — Product Code DXN

K832171 is an FDA 510(k) premarket notification submitted by Ritter Co. for the device "SELF CHECK DIGITAL BLOOD PRESS. MONITOR". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Ritter Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
July 6, 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