Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

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

GE Medical Systems Information Technologies, Inc.

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Monitor B105m, Monitor B125m, Monitor B155m, Monitor B105p, Monitor B125p.

Pre-market Notification Details

• Device ID: K213490
• 510k Number: K213490
• Device Name: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226
• Contact: Joel Kent
• Correspondent: Joel Kent; GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226
• Product Code: MHX
• Subsequent Product Code: BZQ
• Subsequent Product Code: CBQ
• Subsequent Product Code: CBR
• Subsequent Product Code: CBS
• Subsequent Product Code: CCK
• Subsequent Product Code: CCL
• Subsequent Product Code: DPZ
• Subsequent Product Code: DQA
• Subsequent Product Code: DQK
• Subsequent Product Code: DRT
• Subsequent Product Code: DSI
• Subsequent Product Code: DSJ
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: GWQ
• Subsequent Product Code: KOI
• Subsequent Product Code: KRB
• Subsequent Product Code: MLD
• Subsequent Product Code: &nb
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-11-01
• Decision Date: 2022-04-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682147224	K213490	000
00840682147217	K213490	000
00840682146791	K213490	000
00840682146715	K213490	000
00840682146708	K213490	000