510(k) Premarket Notification

• Device Classification Name: monitor,physiological,patient(without arrhythmia detection or alarms)
• 510(K) Number: K101259
• Model: TD-8002
• Device Name: V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
• Applicant: TAIDOC TECHNOLOGY CORPORATION; 6f, no. 127, wugong 2nd rd; wugu township; taipei county,
• Contact: debra liang
• Regulation Number: 870.2300
• Classification Product Code: MWI
• Date Received: 05/04/2010
• Decision Date: 06/17/2010
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No