PATIENT MONITOR

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

ADVANCED INSTRUMENTATIONS, INC.

The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Patient Monitor.

Pre-market Notification Details

• Device ID: K132077
• 510k Number: K132077
• Device Name: PATIENT MONITOR
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET Hialeah, FL 33010
• Contact: Jorge Millan
• Correspondent: Jorge Millan; ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET Hialeah, FL 33010
• Product Code: MHX
• Subsequent Product Code: CBQ
• Subsequent Product Code: CBR
• Subsequent Product Code: CBS
• Subsequent Product Code: CCK
• Subsequent Product Code: CCL
• Subsequent Product Code: DQA
• Subsequent Product Code: DRT
• Subsequent Product Code: DSA
• Subsequent Product Code: DSI
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: MLD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-05
• Decision Date: 2014-04-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B510PM2000TM1	K132077	000
B510PM2000M1	K132077	000