Cleared Traditional

MT8 BIOLOGICAL TELEMETRY SYSTEM (K870901) - FDA 510(k) Clearance

K870901 · Oxford Metrics, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
18d
Days
-
Risk

K870901 is an FDA 510(k) clearance for the MT8 BIOLOGICAL TELEMETRY SYSTEM.

Submitted by Oxford Metrics, Inc. (Tampa, US). The FDA issued a Cleared decision on March 23, 1987 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oxford Metrics, Inc. devices

Submission Details

510(k) Number K870901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date March 23, 1987
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -