HYRDROMAX HMEF— 510(k) K130664

Name: FDA 510(k) clearance K130664
Creator: U.S. Food and Drug Administration
Published: 2013-06-21

Substantially Equivalent

A-M Systems

FDA 510(k) clearance K130664 for HYRDROMAX HMEF, Substantially Equivalent on 2013-06-21. Applicant: A-M Systems. Device class: 2.

Clearance details

Applicant: A-M Systems
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 2013-03-12
Decision date: 2013-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.