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

Clearance details

Applicant

Elcam Medical Acal

Product code

Code DRS

Device class

Class 2

Regulation

21 CFR 870.2850

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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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 →