510(k) Premarket Notification

• Device Classification Name: computer, diagnostic, pre-programmed, single-function
• 510(K) Number: K122247
• Model: HM 81
• Device Name: LIDCORAPID V2 MONITOR
• Applicant: LIDCO LTD.; 16 orsman rd.; london,
• Contact: gregory speller
• Regulation Number: 870.1435
• Classification Product Code: DXG
• Subsequent Product Code: GWQ
• Date Received: 07/27/2012
• Decision Date: 03/20/2013
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• statement: statement
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No