MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

INVIVO CORP.

The following data is part of a premarket notification filed by Invivo Corp. with the FDA for Mri Compatible Patient Monitoring System, Model 865214.

Pre-market Notification Details

• Device ID: K090785
• 510k Number: K090785
• Device Name: MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: INVIVO CORP. 12501 RESEARCH PARKWAY Orlando, FL 32826
• Contact: Rusty Kelly
• Correspondent: Rusty Kelly; INVIVO CORP. 12501 RESEARCH PARKWAY Orlando, FL 32826
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-23
• Decision Date: 2009-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838101449	K090785	000
00884838029736	K090785	000
00884838030213	K090785	000
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