510(k) Premarket Notification

• Device Classification Name: warmer, thermal, infusion fluid
• 510(K) Number: K120860
• Device Name: INFU BOX TYPE 0412A
• Applicant: MEDICAL RESCUE EQUIPMENT HOLDING AS; postboks 186; porsgrunn,
• Contact: knut fangberget
• Classification Product Code: LGZ
• Date Received: 03/22/2012
• Decision Date: 05/08/2012
• 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