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

Name: FDA 510(k) clearance K073712
Creator: U.S. Food and Drug Administration
Published: 2008-06-06

Substantially Equivalent

Adroit Medical Systems, Inc.

FDA 510(k) clearance K073712 for SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100, Substantially Equivalent on 2008-06-06. Applicant: Adroit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Adroit Medical Systems, Inc.
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2007-12-31
Decision date: 2008-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Loudon, TN, US

Download summary PDF View on FDA.gov ↗

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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.