TELEMETRY SYSTEM 315— 510(k) K790144

Name: FDA 510(k) clearance K790144
Creator: U.S. Food and Drug Administration
Published: 1979-02-23

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K790144 for TELEMETRY SYSTEM 315, Substantially Equivalent on 1979-02-23. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 1979-01-19
Decision date: 1979-02-23
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 DRG

product code DRG

Death: 5
Total: 5

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.