Cleared Traditional

K852034 - VITATRON M (FDA 510(k) Clearance)

K852034 · Elmed, Inc. · Physical Medicine device
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Jan 1986
Decision
239d
Days
-
Risk

K852034 is an FDA 510(k) clearance for the VITATRON M.

Submitted by Elmed, Inc. (Addison, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 239 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Elmed, Inc. devices

Submission Details

510(k) Number K852034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date January 03, 1986
Days to Decision 239 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 115d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -