IMEX RHYTHM TEK— 510(k) K890114

Name: FDA 510(k) clearance K890114
Creator: U.S. Food and Drug Administration
Published: 1989-07-27

Substantially Equivalent

Racom, Inc.

FDA 510(k) clearance K890114 for IMEX RHYTHM TEK, Substantially Equivalent on 1989-07-27. Applicant: Racom, Inc.. Device class: 2.

Clearance details

Applicant: Racom, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1989-01-11
Decision date: 1989-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rg7 4lp, Berkshire, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.