PATIENT MONITOR

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

SHENZHEN CREATIVE INDUSTRY CO., LTD

The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd with the FDA for Patient Monitor.

Pre-market Notification Details

• Device ID: K123711
• 510k Number: K123711
• Device Name: PATIENT MONITOR
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: SHENZHEN CREATIVE INDUSTRY CO., LTD 12226 WASHINGTON LANE Parker, AZ 85344
• Contact: Charlie Mack
• Correspondent: Charlie Mack; SHENZHEN CREATIVE INDUSTRY CO., LTD 12226 WASHINGTON LANE Parker, AZ 85344
• Product Code: MWI
• Subsequent Product Code: CCK
• Subsequent Product Code: DQA
• Subsequent Product Code: DXN
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-04
• Decision Date: 2013-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B377GMDTVSBPO2T0	K123711	000
06941900604285	K123711	000