GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

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

GENERAL MEDITECH, INC.

The following data is part of a premarket notification filed by General Meditech, Inc. with the FDA for General Patient Monitors, Models: G3c/ G3d/ G3f/ G3g/ G3h.

Pre-market Notification Details

Device IDK092970
510k NumberK092970
Device Name:GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GENERAL MEDITECH, INC. SUITE 5D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai,  CN 200030
ContactLee Fu
CorrespondentLee Fu
GENERAL MEDITECH, INC. SUITE 5D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai,  CN 200030
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-25
Decision Date2010-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06938368100244 K092970 000
06938368100428 K092970 000
06938368100404 K092970 000
06938368100398 K092970 000
06938368100381 K092970 000
06938368100374 K092970 000
06938368100367 K092970 000
06938368100350 K092970 000
06938368100343 K092970 000
06938368100053 K092970 000
06938368100077 K092970 000
06938368100237 K092970 000
06938368100213 K092970 000
06938368100190 K092970 000
06938368100176 K092970 000
06938368100152 K092970 000
06938368100138 K092970 000
06938368100114 K092970 000
06938368100091 K092970 000
06938368100336 K092970 000

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