Cleared Traditional

K843840 - N2 TEST
(FDA 510(k) Clearance)

Oct 1984
Decision
11d
Days
Risk

K843840 is an FDA 510(k) clearance for the N2 TEST..

Submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on October 12, 1984, 11 days after receiving the submission on October 1, 1984.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K843840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date October 12, 1984
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code
Device Class