MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M

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

INVIVO RESEARCH, INC.

The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Magnitude 3150m Mri Patient Monitor, Model 3150m.

Pre-market Notification Details

• Device ID: K040915
• 510k Number: K040915
• Device Name: MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826
• Contact: Neil Battiste
• Correspondent: Neil Battiste; INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-08
• Decision Date: 2004-09-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838033757	K040915	000
00884838004979	K040915	000