BEAR JET VENTILATOR FOR USE DURING (ESWL)— 510(k) K871985

Substantially Equivalent

Bear Medical Systems, Inc.

FDA 510(k) clearance K871985 for BEAR JET VENTILATOR FOR USE DURING (ESWL), Substantially Equivalent on 1987-06-15. Applicant: Bear Medical Systems, Inc..

Clearance details

Applicant: Bear Medical Systems, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1987-05-22
Decision date: 1987-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.