SENTORR ARTERIAL PRESSURE SENSOR— 510(k) K880830

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K880830 for SENTORR ARTERIAL PRESSURE SENSOR, Substantially Equivalent on 1988-08-12. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1988-03-01
Decision date: 1988-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.