COACH TM- THE AEROBIC FITNESS MONITOR— 510(k) K851335

Substantially Equivalent

Biotechnology, Inc.

FDA 510(k) clearance K851335 for COACH TM- THE AEROBIC FITNESS MONITOR, Substantially Equivalent on 1985-07-24. Applicant: Biotechnology, Inc..

Clearance details

Applicant: Biotechnology, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1985-04-03
Decision date: 1985-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.