510(k) Premarket Notification

• Device Classification Name: detector and alarm, arrhythmia
• 510(K) Number: K120774
• Model: 020XXXX (WHERE XXXX= VARIOUS CONFIG), MOBILE ACUITY AKA MOBILE LT
• Device Name: ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
• Applicant: WELCH ALLYN, INC.; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153 0220
• Contact: kevin crossen
• Regulation Number: 870.1025
• Classification Product Code: DSI
• Date Received: 03/14/2012
• Decision Date: 04/10/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No