ELECTROCARDIOGRAPH (74 DPS) #YM-102— 510(k) K822768

Name: FDA 510(k) clearance K822768
Creator: U.S. Food and Drug Administration
Published: 1982-10-04

Substantially Equivalent

Sanyo Electric, Inc.

FDA 510(k) clearance K822768 for ELECTROCARDIOGRAPH (74 DPS) #YM-102, Substantially Equivalent on 1982-10-04. Applicant: Sanyo Electric, Inc.. Device class: 2.

Clearance details

Applicant: Sanyo Electric, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1982-09-14
Decision date: 1982-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.