THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS— 510(k) K071958

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K071958 for THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS, Substantially Equivalent on 2007-11-21. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2007-07-16
Decision date: 2007-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, 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.