MINISCOPE MS-2B ELECTROCARDIOSCOPE— 510(k) K791421

Name: FDA 510(k) clearance K791421
Creator: U.S. Food and Drug Administration
Published: 1979-08-28

Substantially Equivalent

Renesco International, Inc.

FDA 510(k) clearance K791421 for MINISCOPE MS-2B ELECTROCARDIOSCOPE, Substantially Equivalent on 1979-08-28. Applicant: Renesco International, Inc.. Device class: 2.

Clearance details

Applicant: Renesco International, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1979-07-16
Decision date: 1979-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K800659 — SCHILLER MSG-11980-04-08
K791422 — MINISPIROMETER SP-11979-11-05
K791420 — MINIGRAPH MG-I ELECTROCARDIOGRAPH1979-08-28

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.