4003 AEROLITE— 510(k) K942208

Substantially Equivalent

Medical Industries America, Inc.

FDA 510(k) clearance K942208 for 4003 AEROLITE, Substantially Equivalent on 1995-02-24. Applicant: Medical Industries America, Inc..

Clearance details

Applicant: Medical Industries America, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1994-05-05
Decision date: 1995-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Adel, IA, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.