PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE— 510(k) K040178

Substantially Equivalent

S.P.O. Medical Equipment, Ltd.

FDA 510(k) clearance K040178 for PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE, Substantially Equivalent on 2004-09-10. Applicant: S.P.O. Medical Equipment, Ltd..

Clearance details

Applicant: S.P.O. Medical Equipment, Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2004-01-26
Decision date: 2004-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

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.