4/1/2004
LTV® 1000 Receives FDA 510(k) Release for 5 kg Application
Minneapolis, Minnesota
Pulmonetic Systems, Inc., has received 510(k) release from the Food & Drug Administration (FDA) for the LTV® 1000 ventilator’s intended use on pediatric patients 5 kg and larger. The 5 kg release represents a significant step forward in the pediatric application of the LTV, which had previously only been approved for intended use on patients 10 kg and larger. Letters to File have also been prepared for the LTV® 950, LTV® 900 and LTV® 800.
For a PDF version of the 510(k) release from the FDA, click here.
If you would like more information, please contact our Marketing Department at 866-752-1438 or email us at info@pulmonetic.com
Pulmonetic Systems, Inc. designs, manufactures, and markets innovative products for respiratory care worldwide. The hallmark LTV® Series ventilators are a result of the company’s dedication to offering products that provide better patient care and economic value for the healthcare provider.