HIGH IMPEDANCE CARDIAC GATING CABLE

System, Nuclear Magnetic Resonance Imaging

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for High Impedance Cardiac Gating Cable.

Pre-market Notification Details

• Device ID: K981190
• 510k Number: K981190
• Device Name: HIGH IMPEDANCE CARDIAC GATING CABLE
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188
• Contact: Larry Kroger
• Correspondent: Larry Kroger; GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-04-02
• Decision Date: 1998-06-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682102452	K981190	000