BEAR NICU-1— 510(k) K853346

Substantially Equivalent

Bear Medical Systems, Inc.

FDA 510(k) clearance K853346 for BEAR NICU-1, Substantially Equivalent on 1985-09-11. Applicant: Bear Medical Systems, Inc..

Clearance details

Applicant: Bear Medical Systems, Inc.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1985-08-12
Decision date: 1985-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.