MEDSAT OXYGEN SATURATION SYSTEM— 510(k) K941922

Substantially Equivalent

Medtronic Bio-Medicus, Inc.

FDA 510(k) clearance K941922 for MEDSAT OXYGEN SATURATION SYSTEM, Substantially Equivalent on 1995-02-17. Applicant: Medtronic Bio-Medicus, Inc..

Clearance details

Applicant: Medtronic Bio-Medicus, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1994-04-20
Decision date: 1995-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.