K082546

Substantially Equivalent

REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)

Applicant: Unimed Medical Supplies, Inc.
Product code: DQA
Advisory panel: Cardiovascular
Date received: 2008-09-03
Decision date: 2008-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mukwonago, WI, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.