Cleared Traditional

K030230 - AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) (FDA 510(k) Clearance)

K030230 · Avita Corporation · Cardiovascular device

May 2003

Decision

121d

Days

Class 2

Risk

K030230 is an FDA 510(k) clearance for the AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).

Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on May 23, 2003, 121 days after receiving the submission on January 22, 2003.

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

Submission Details

510(k) Number	K030230 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 22, 2003
Decision Date	May 23, 2003
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF