DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420— 510(k) K040380

Substantially Equivalent

Dolphin Medical, Inc.

FDA 510(k) clearance K040380 for DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420, Substantially Equivalent on 2004-08-31. Applicant: Dolphin Medical, Inc..

Clearance details

Applicant: Dolphin Medical, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2004-02-17
Decision date: 2004-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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.