510(k) Premarket Notification

• Device Classification Name: thermometer, electronic, clinical
• 510(K) Number: K121118
• Model: TD-1261 A, TD-1261B
• Device Name: FORA COMFORTSCAN EAR THERMOMETER
• Applicant: FORA CARE INC.; 3f, 5f, 6f, no.127, wugong; 2nd rd., wugu township; taipei county,
• Contact: pinjung chen
• Regulation Number: 880.2910
• Classification Product Code: FLL
• Date Received: 04/12/2012
• Decision Date: 06/15/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No