COMPONENT NEUROMONITORING SYSTEM

Amplitude-integrated Electroencephalograph

MOBERG RESEARCH, INC.

The following data is part of a premarket notification filed by Moberg Research, Inc. with the FDA for Component Neuromonitoring System.

Pre-market Notification Details

• Device ID: K080217
• 510k Number: K080217
• Device Name: COMPONENT NEUROMONITORING SYSTEM
• Classification: Amplitude-integrated Electroencephalograph
• Applicant: MOBERG RESEARCH, INC. 224 S. MAPLE WAY Ambler, PA 19002
• Contact: Damon Lees
• Correspondent: Robert Mosenkis; CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298
• Product Code: OMA
• Subsequent Product Code: GWQ
• Subsequent Product Code: MHX
• Subsequent Product Code: MUD
• Subsequent Product Code: OLT
• Subsequent Product Code: ORT
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-01-29
• Decision Date: 2008-11-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B485CNSPTZ3101	K080217	000
B485CNS3101	K080217	000
B485CNS3001	K080217	000
B485CNSVID3701	K080217	000
B485CNSVID3501	K080217	000
B485CNS3501	K080217	000
B485CNSPTZ3501	K080217	000
00382830063029	K080217	000
00382830063012	K080217	000
00382830063005	K080217	000
00382830062985	K080217	000
00382830062961	K080217	000
00382830062954	K080217	000
B485CNS3201	K080217	000
B485CNSEEG2001	K080217	000
B485CNSPTZ3001	K080217	000
B485CNSVID3201	K080217	000
B485CNSVID3101	K080217	000
B485CNSVID3001	K080217	000
B485CNSINX3201	K080217	000
B485CNSINX3101	K080217	000
B485CNSINX3001	K080217	000
B485CNSEEG3201	K080217	000
B485CNSEEG3101	K080217	000
B485CNSEEG3001	K080217	000
B485CNSEEG2201	K080217	000
B485CNSEEG2101	K080217	000
00382830062947	K080217	000