K873488

Substantially Equivalent

SILENT GUARD CAT. NO. SG-10

Applicant: American Omni Medical, Inc.
Product code: DTL
Advisory panel: Cardiovascular
Date received: 1987-08-31
Decision date: 1987-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.