MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Mri Monitor With L-cane05 And L-cane05a Software And Module Options N-psngv, N-psng, N-sngv, N-sng, N-psn, N-sn.

Pre-market Notification Details

• Device ID: K062324
• 510k Number: K062324
• Device Name: MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492
• Contact: Joel Kent
• Correspondent: Joel Kent; GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-09
• Decision Date: 2006-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682103077	K062324	000
00840682103022	K062324	000