510(k) Premarket Notification

• Device Classification Name: ventilator, non-continuous (respirator)
• 510(K) Number: K121747
• Device Name: FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
• Applicant: INTERSURGICAL INCORPORATED; 417 electronics parkway; liverpool, NY 13088
• Contact: michael zalewski
• Regulation Number: 868.5905
• Classification Product Code: BZD
• Date Received: 06/14/2012
• Decision Date: 03/14/2013
• 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