SULLIVAN HUMIDAIRE HEATED HUMIDIFIER— 510(k) K971260

Substantially Equivalent

Resmed Corp

FDA 510(k) clearance K971260 for SULLIVAN HUMIDAIRE HEATED HUMIDIFIER, Substantially Equivalent on 1997-09-04. Applicant: Resmed Corp.

Clearance details

Applicant: Resmed Corp
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 1997-04-04
Decision date: 1997-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.