LIFEGUARD NASAL CPAP MASK AND ACCESSORIES— 510(k) K013421

Substantially Equivalent

Lifeguard Medical Products, Inc.

FDA 510(k) clearance K013421 for LIFEGUARD NASAL CPAP MASK AND ACCESSORIES, Substantially Equivalent on 2002-01-08. Applicant: Lifeguard Medical Products, Inc..

Clearance details

Applicant: Lifeguard Medical Products, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2001-10-16
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainfield, IN, 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.