510(k) Premarket Notification

• Device Classification Name: calculator, predicted values, pulmonary function
• 510(K) Number: K122699
• Models: APS PRO/MASTERSCREEN PFT, MASTERSCREEN PFT BODY/MASTERSCEEN BODY DIFF, MS PNEUMO/MASTERSCEEN IOS/
• Device Name: SENTRYSUITE PRODUCT LINE
• Applicant: CAREFUSION GERMANY 234 GMBH; leibnizstrasse 7; hoechberg,
• Contact: elmar niedermeyer
• Regulation Number: 868.1890
• Classification Product Code: BTY
• Subsequent Product Codes: BZC BZG JEH
• Date Received: 09/04/2012
• Decision Date: 11/19/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Anesthesiology
• Review Advisory Committee: Anesthesiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No