DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES— 510(k) K935782

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K935782 for DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES, Substantially Equivalent on 1994-08-01. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1993-12-06
Decision date: 1994-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, CA, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.