510(k) K932561— GUEDEL AIRWAYS

Substantially Equivalent

Life Shield Healthcare Products, Inc.

Clearance details

Applicant: Life Shield Healthcare Products, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1993-05-27
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noblesville, IN, US

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.