CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER— 510(k) K974301

Substantially Equivalent

Clk Intl., Inc.

FDA 510(k) clearance K974301 for CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER, Substantially Equivalent on 1998-02-06. Applicant: Clk Intl., Inc..

Clearance details

Applicant: Clk Intl., Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1997-11-17
Decision date: 1998-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.