INHALATOR MODELS 8100, 10100 AND 10200— 510(k) K862194

Substantially Equivalent

U.O. Equipment Co.

FDA 510(k) clearance K862194 for INHALATOR MODELS 8100, 10100 AND 10200, Substantially Equivalent on 1986-07-28. Applicant: U.O. Equipment Co..

Clearance details

Applicant: U.O. Equipment Co.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1986-06-09
Decision date: 1986-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.