Cleared Traditional

K802805 - NEMECTRODYN 5

K802805 · Nemectron Medical, Inc. · Physical Medicine device
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Nov 1980
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K802805 is an FDA 510(k) clearance for the NEMECTRODYN 5.

Submitted by Nemectron Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1980.

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 Nemectron Medical, Inc. devices

FDA 510(k) Submission Details - K802805

510(k) Number K802805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received November 05, 1980
Decision Date November 05, 1980
Days to Decision -
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -