IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2— 510(k) K131901

Substantially Equivalent

3B Medical, Inc.

FDA 510(k) clearance K131901 for IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2, Substantially Equivalent on 2013-12-23. Applicant: 3B Medical, Inc..

Clearance details

Applicant: 3B Medical, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2013-06-25
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Wales, FL, 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.