K881006

Substantially Equivalent

STOCKERT-SHILEY BUBBLE MONITOR 23-23-01

Applicant: Shiley, Inc.
Product code: DRY
Advisory panel: Cardiovascular
Date received: 1988-03-09
Decision date: 1988-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.