Cleared Traditional

K843859 - LAUF-ERGOTEST JUNIOR
(FDA 510(k) Clearance)

Nov 1984
Decision
57d
Days
Class 1
Risk

K843859 is an FDA 510(k) clearance for the LAUF-ERGOTEST JUNIOR. This device is classified as a Treadmill, Powered (Class I - General Controls, product code IOL).

Submitted by Erich Jaeger, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1984, 57 days after receiving the submission on October 1, 1984.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K843859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date November 27, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IOL — Treadmill, Powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.5380

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