510(k) K822055

CNIBP BLOOD PRESSURE MEASUREMENT SYS by Ohio Medical Products — Product Code DXN

K822055 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "CNIBP BLOOD PRESSURE MEASUREMENT SYS". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
July 13, 1982
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