SILENT GUARD CAT. NO. SG-30— 510(k) K851465

Name: FDA 510(k) clearance K851465
Creator: U.S. Food and Drug Administration
Published: 1985-08-05

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K851465 for SILENT GUARD CAT. NO. SG-30, Substantially Equivalent on 1985-08-05. Applicant: American Omni Medical, Inc.. Device class: 2.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1985-04-11
Decision date: 1985-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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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.