510(k) K073712— SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100

Substantially Equivalent

Adroit Medical Systems, Inc.

Clearance details

Applicant: Adroit Medical Systems, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2007-12-31
Decision date: 2008-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Loudon, TN, US

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.