Cleared Traditional

K850087 - BIOLOGICAL TELEMETRY SYSTEM

K850087 · Chattanooga Group, Inc. · Physical Medicine device
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Apr 1985
Decision
95d
Days
-
Risk

K850087 is an FDA 510(k) clearance for the BIOLOGICAL TELEMETRY SYSTEM.

Submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on April 16, 1985 after a review of 95 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.

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FDA 510(k) Submission Details - K850087

510(k) Number K850087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1985
Decision Date April 16, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -