Cleared Traditional

K893254 - DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER
(FDA 510(k) Clearance)

Jan 1990
Decision
249d
Days
Class 1
Risk

K893254 is an FDA 510(k) clearance for the DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER. This device is classified as a Platform, Force-measuring (Class I - General Controls, product code KHX).

Submitted by Dalphi, Inc. (Washington, US). The FDA issued a Cleared decision on January 2, 1990, 249 days after receiving the submission on April 28, 1989.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1575.

Submission Details

510(k) Number K893254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1989
Decision Date January 02, 1990
Days to Decision 249 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code KHX — Platform, Force-measuring
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.1575

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