VX4 RECORDING PULSE OXIMETER— 510(k) K935510

Substantially Equivalent

Vitalog Monitoring,Inc.

FDA 510(k) clearance K935510 for VX4 RECORDING PULSE OXIMETER, Substantially Equivalent on 1994-07-01. Applicant: Vitalog Monitoring,Inc..

Clearance details

Applicant: Vitalog Monitoring,Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1993-11-16
Decision date: 1994-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood, CA, 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.