Cleared Traditional

P105 (K820827) - FDA 510(k) Clearance

K820827 · Eurotan Intl. · Physical Medicine device
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Jun 1982
Decision
91d
Days
-
Risk

K820827 is an FDA 510(k) clearance for the P105.

Submitted by Eurotan Intl. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 91 days - within the typical 510(k) review window.

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 Eurotan Intl. devices

Submission Details

510(k) Number K820827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1982
Decision Date June 25, 1982
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -