ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER— 510(k) K903136

Name: FDA 510(k) clearance K903136
Creator: U.S. Food and Drug Administration
Published: 1991-01-18

Substantially Equivalent

Arzco Medical Electronics, Inc.

FDA 510(k) clearance K903136 for ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER, Substantially Equivalent on 1991-01-18. Applicant: Arzco Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Arzco Medical Electronics, Inc.
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1990-07-17
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.