VITALSAT PULSE OXIMETER, MODEL IC32000— 510(k) K011365

Substantially Equivalent

Island Critical Care Corp.

FDA 510(k) clearance K011365 for VITALSAT PULSE OXIMETER, MODEL IC32000, Substantially Equivalent on 2001-10-26. Applicant: Island Critical Care Corp..

Clearance details

Applicant: Island Critical Care Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-05-04
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stratford, P.E.I., CA

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.