TYPE 9210 ECG SYSTEM ATHENA— 510(k) K884117

Name: FDA 510(k) clearance K884117
Creator: U.S. Food and Drug Administration
Published: 1989-04-26

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K884117 for TYPE 9210 ECG SYSTEM ATHENA, Substantially Equivalent on 1989-04-26. Applicant: S & W Medico Teknik. Device class: 2.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1988-09-30
Decision date: 1989-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

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K234003 — The Circadia C200 System2024-05-30

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K915633 — MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA1993-06-29
K930134 — 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT1993-04-09
K923418 — 9293/1 INTERFACE MODULE1993-02-23

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.