Track Record

Over 70 510(k) submissions successfully submitted to FDA for review and clearance

• First 3.0T MRI-compatible oxygen cylinder - 2003
  • K033897 (FDA website)
  • 510(k) Summary
• First infrared OTC digital forehead thermometer - 2002
  • K020433 (FDA website)
  • 510(k) Summary
• First electronic device submission to FDA - 1998
  • K982157 (FDA website)
  • 510(k) Summary
• First laparoscopic ultrasound system and transducers - 1995
  • K945796 (FDA website)
  • 510(k) Summary