Cleared Traditional

K850868 - MFE CARDIAC STRESS SYSTEM (FDA 510(k) Clearance)

K850868 · Ketronic, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
103d
Days
-
Risk

K850868 is an FDA 510(k) clearance for the MFE CARDIAC STRESS SYSTEM.

Submitted by Ketronic, Inc. (The Netherlands, NL). The FDA issued a Cleared decision on June 12, 1985 after a review of 103 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 Ketronic, Inc. devices

Submission Details

510(k) Number K850868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date June 12, 1985
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -