REGULATORY TECHNOLOGY SERVICES INC Information

Regulatory Technology Services LLC is a limited liability company registered with the state of Minnesota. Regulatory Technology Services LLC currently employs one person full-time and three part-time staff to complete reviews to meet customer requirements. The sole business purpose of Regulatory Technology Services LLC, is to perform third-party reviews of 510(k) submissions under the FDA Accredited Person Program. Devices that have been reviewed by Regulatory Technology Services include*: Nebulizers Cardiovascular Catheters Surgical Lasers NIBP Monitors ECG monitors X-ray systems Ultrasound systems CT and MRIs Picture Archiving Systems (PACS) *This list is not inclusive of all types of products reviewed by Regulatory Technology Services LLC. Through May 2012, Regulatory Technology Services has reviewed more than 400 submissions. Through this experience with both Regulatory Techology Services and within industry, Regulatory Technology Services' primary reviewer has reviewed more than 500 510(k) submissions.