INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000— 510(k) K031176

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K031176 for INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000, Substantially Equivalent on 2004-03-25. Applicant: Invacare Corp..

Clearance details

Applicant: Invacare Corp.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2003-04-14
Decision date: 2004-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.