510(k) Premarket Notification

• Device Classification Name: Ventilator, Continuous, Facility Use
• 510(k) Number: K982910
• Device Name: HAMILTON MEDICAL GALILEOVENTILATOR
• Applicant: HAMILTON MEDICAL, INC.; 505 EDISON WAY; P.O. BOX 30008; RENO, NV 89520
• Applicant Contact: J. DAVID THOMPSON
• Correspondent: HAMILTON MEDICAL, INC.; 505 EDISON WAY; P.O. BOX 30008; RENO, NV 89520
• Correspondent Contact: J. DAVID THOMPSON
• Regulation Number: 868.5895
• Classification Product Code: CBK
• Date Received: 08/18/1998
• Decision Date: 09/14/1999
• Decision: SE SUBJECT TO TRACKING REG (ST)
• Regulation Medical Specialty: Anesthesiology
• 510k Review Panel: Anesthesiology
• Summary: Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No