PATIENT MONITOR

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

ADVANCED INSTRUMENTS, INC.

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

Pre-market Notification Details

Device IDK120631
510k NumberK120631
Device Name:PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant ADVANCED INSTRUMENTS, INC. 601 WEST 20 ST Hialeah,  FL  33010
ContactJorge Millan
CorrespondentJorge Millan
ADVANCED INSTRUMENTS, INC. 601 WEST 20 ST Hialeah,  FL  33010
Product CodeMHX  
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSA
Subsequent Product CodeDSF
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-01
Decision Date2012-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B510PM2000XLPRO1 K120631 000
B510PM2000XLPLUS1 K120631 000
B510PM2000XL1 K120631 000

Trademark Results [PATIENT MONITOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PATIENT MONITOR
PATIENT MONITOR
74564296 1942340 Live/Registered
Brown, Frank L.
1994-08-22

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