TES-20— 510(k) K992425

Name: FDA 510(k) clearance K992425
Creator: U.S. Food and Drug Administration
Published: 1999-10-19

Substantially Equivalent

Tes Electrical Electronic Corp.

FDA 510(k) clearance K992425 for TES-20, Substantially Equivalent on 1999-10-19. Applicant: Tes Electrical Electronic Corp.. Device class: 2.

Clearance details

Applicant: Tes Electrical Electronic Corp.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1999-07-21
Decision date: 1999-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Taiwan 300, CN

Download summary PDF View on FDA.gov ↗

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K231424 — HeartBeam AIMIGo(TM) System2024-12-13
K233864 — ASSURE Wearable ECG2024-05-07

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.