Cleared Traditional

K200346 - Wrist Type Blood Pressure Monitor (FDA 510(k) Clearance)

K200346 · Avita Corporation · Cardiovascular device

Dec 2020

Decision

310d

Days

Class 2

Risk

K200346 is an FDA 510(k) clearance for the Wrist Type Blood Pressure Monitor. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).

Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 17, 2020, 310 days after receiving the submission on February 11, 2020.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number	K200346 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 11, 2020
Decision Date	December 17, 2020
Days to Decision	310 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF