TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017— 510(k) K010578

Substantially Equivalent

Taga Medical Technologies, Inc.

FDA 510(k) clearance K010578 for TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017, Substantially Equivalent on 2001-04-25. Applicant: Taga Medical Technologies, Inc..

Clearance details

Applicant: Taga Medical Technologies, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2001-02-27
Decision date: 2001-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, 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.