MINDCHILD MEDICAL

Address:1600 Osgood St Ste 2017,North Andover,MA,01845,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Monitoring, Perinatal (HGM) (3)

Premarket Exempt

Yes

Clear

Meridian M110 Fetal Monitoring System - 00867696000307 Catalog Number :

Device Description : The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that e The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MERIDIAN M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals.

Device Class : 2

Duns Number: 020091217

Premarket Exempt : Yes

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Meridian Disposable fECG Electrode Patch - 00867696000321 Catalog Number :

Device Description : The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mo The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides, which provides continuous fetal signal capture during fetal movement.

Device Class : 2

Duns Number: 020091217

Premarket Exempt : Yes

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Meridian Cable Set - 00867696000352 Catalog Number :

Device Class : 2

Duns Number: 020091217

Premarket Exempt : Yes

Product Code : HGM

Prescription Use : Yes

Device Count : 1

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