Cleared Traditional

K842599 - METER MOUSE SYSTEM (FDA 510(k) Clearance)

K842599 · Mem, Inc. · Radiology device
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Oct 1984
Decision
91d
Days
-
Risk

K842599 is an FDA 510(k) clearance for the METER MOUSE SYSTEM.

Submitted by Mem, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mem, Inc. devices

Submission Details

510(k) Number K842599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date October 02, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -