DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070— 510(k) K012989

Substantially Equivalent

Dolphin Medical, Inc.

FDA 510(k) clearance K012989 for DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070, Substantially Equivalent on 2002-03-20. Applicant: Dolphin Medical, Inc..

Clearance details

Applicant: Dolphin Medical, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-09-06
Decision date: 2002-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highlands Ranch, CO, 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.