510(k) K222658

Accurate 24 Non-invasive blood pressure monitor by Accurate Meditech, Inc. — Product Code DXN

K222658 is an FDA 510(k) premarket notification submitted by Accurate Meditech, Inc. for the device "Accurate 24 Non-invasive blood pressure monitor". The FDA issued a decision of Substantially Equivalent on June 21, 2023. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Accurate Meditech, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2023
Date Received
September 2, 2022
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