Search Results

The ATMOS E 201 Thorax and the ATMOS S 201 Thorax are indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious material from a patient's respiratory support system after surgery. The general indication of the ATMOS S 201 Thorax and the ATMOS E 201 Thorax is thoracic drainage.

The ATMOS S 201 Thorax and ATMOS E 201 Thorax drainage suction units are devices for mobile thoracic drainage. The devices are intended for short-time (

This 510(k) summary does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The document (510(k) Summary of Safety and Effectiveness for the ATMOS S 201 Thorax and ATMOS E 201 Thorax) states:

• "The ATMOS S 201 Thorax and ATMOS E 201 Thorax devices have been designed and tested to applicable safety standards and do not raise any new issues of safety, efficacy, or performance of the product."
• "The 510(k) for the ATMOS S 201 Thorax and ATMOS E 201 Thorax devices contains adequate information and data to enable FDA to determine substantial equivalence to the predicate devices. The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey."

However, it does not provide details on specific acceptance criteria, performance metrics, or the actual study results that demonstrate the device meets any specific performance targets. It relies on the claim of "substantial equivalence" to predicate devices and adherence to voluntary safety standards, rather than detailing a specific performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device