Cleared Traditional

K896958 - ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
(FDA 510(k) Clearance)

K896958 · Medical Data Electronics · Cardiovascular
Mar 1990
Decision
89d
Days
Class 2
Risk

K896958 is an FDA 510(k) clearance for the ESCORT NON-INVASIVE BLOOD PRESSURE OPTION. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN).

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on March 13, 1990, 89 days after receiving the submission on December 14, 1989.

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

Submission Details

510(k) Number K896958 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1989
Decision Date March 13, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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