MINOLTA PULSOX-3/MINOLTA PULSOX-3I— 510(k) K984570

Substantially Equivalent

In-X Corp.

FDA 510(k) clearance K984570 for MINOLTA PULSOX-3/MINOLTA PULSOX-3I, Substantially Equivalent on 2000-08-30. Applicant: In-X Corp..

Clearance details

Applicant: In-X Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1998-12-23
Decision date: 2000-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, 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.