The product had to meet the following criteria:
> Meets AAMI/ANSI/ES60601-1 Standards for electrical safety
> Provides a constant vacuum of <= 90 mmHg at a constant flowrate of 42 L/m in accordance with FDA regulations.
> Compatible with Sedation Systems’ Analgesia system, flowmeter, and Vent Connector.
> Designed within the limits of an existing 510k.
> Be assembled in an FDA-approved manufacturing facility.