MODEL HEC-7 HEART EVALUATION COMPUTER— 510(k) K802952

Name: FDA 510(k) clearance K802952
Creator: U.S. Food and Drug Administration
Published: 1981-01-07

Substantially Equivalent

Kluwe Corp.

FDA 510(k) clearance K802952 for MODEL HEC-7 HEART EVALUATION COMPUTER, Substantially Equivalent on 1981-01-07. Applicant: Kluwe Corp.. Device class: 2.

Clearance details

Applicant: Kluwe Corp.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1980-11-20
Decision date: 1981-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

view all

K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

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.