PULSE HEART RATE MONITOR— 510(k) K943243

Name: FDA 510(k) clearance K943243
Creator: U.S. Food and Drug Administration
Published: 1995-03-10

Substantially Equivalent

Sensor Dynamics, Inc.

FDA 510(k) clearance K943243 for PULSE HEART RATE MONITOR, Substantially Equivalent on 1995-03-10. Applicant: Sensor Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Sensor Dynamics, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1994-07-06
Decision date: 1995-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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K943242 — PRO-SPORT HEART RATE MONITOR1995-03-10

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.