ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)— 510(k) K120624

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K120624 for ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT), Substantially Equivalent on 2012-06-08. Applicant: Elcam Medical Acal.

Clearance details

Applicant: Elcam Medical Acal
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2012-03-01
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbutz Baram, IL

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.