MONITOR, PACEMAKER— 510(k) K770865

Name: FDA 510(k) clearance K770865
Creator: U.S. Food and Drug Administration
Published: 1977-06-14

Substantially Equivalent

Adcor Electronics, Inc.

FDA 510(k) clearance K770865 for MONITOR, PACEMAKER, Substantially Equivalent on 1977-06-14. Applicant: Adcor Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Adcor Electronics, Inc.
Product code: Code DTC
Device class: Class 2
Regulation: 21 CFR 870.3630
Advisory panel: Cardiovascular
Date received: 1977-05-11
Decision date: 1977-06-14
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 DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.