VENTRI

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS F.I. HAIFA

The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Ventri.

Pre-market Notification Details

• Device ID: K051855
• 510k Number: K051855
• Device Name: VENTRI
• Classification: System, Tomography, Computed, Emission
• Applicant: GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200
• Contact: Eli Werner
• Correspondent: Alex Grob; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2005-07-08
• Decision Date: 2005-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682121644	K051855	000