ECG PATIENT MONITOR 301— 510(k) K850156

Substantially Equivalent

Rigel Medical Electronics, Inc.

FDA 510(k) clearance K850156 for ECG PATIENT MONITOR 301, Substantially Equivalent on 1985-03-01. Applicant: Rigel Medical Electronics, Inc..

Clearance details

Applicant: Rigel Medical Electronics, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1985-01-15
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mill Valley, CA, 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.