ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530— 510(k) K012207

Substantially Equivalent

Tiara Medical Systems, Inc.

FDA 510(k) clearance K012207 for ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530, Substantially Equivalent on 2001-07-23. Applicant: Tiara Medical Systems, Inc..

Clearance details

Applicant: Tiara Medical Systems, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2001-07-16
Decision date: 2001-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Lakewood, OH, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.