DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421— 510(k) K030952

Substantially Equivalent

Dolphin Medical, Inc.

FDA 510(k) clearance K030952 for DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421, Substantially Equivalent on 2003-05-19. Applicant: Dolphin Medical, Inc..

Clearance details

Applicant: Dolphin Medical, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2003-03-26
Decision date: 2003-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Highlands Ranch, CO, 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.