ZOE MEDICAL INCORPORATED

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Filters

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

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (6) Oximeter (DQA) (4) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4)

Premarket Exempt

Clear

Ultraview DM3 - 00851920007002 Catalog Number : 175-6100

Device Description : The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming ba

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : DQA, DXN

Prescription Use : Yes

Device Count : 1

Ultraview DM3 - 00851920007019 Catalog Number : 175-6110

Device Description : The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming ba

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : DXN, DQA

Prescription Use : Yes

Device Count : 1

Ultraview DM3 - 00851920007026 Catalog Number : 175-6200

Device Description : The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming ba

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : DXN, DQA

Prescription Use : Yes

Device Count : 1

Ultraview DM3 - 00851920007033 Catalog Number : 175-6210

Device Description : The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming ba

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : DXN, DQA

Prescription Use : Yes

Device Count : 1

Nightingale Monitoring System - 00851920007040 Catalog Number : 179-0003

Device Description : The Nightingale PPM3 Monitor is intended for monitoring, recording, and alarming

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

740 SELECT - 00851920007057 Catalog Number : 01-02-1000

Device Description : The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

740 SELECT - 00851920007064 Catalog Number : 01-02-1001

Device Description : The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

740 SELECT - 00851920007071 Catalog Number : 01-02-1002

Device Description : The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

740 SELECT - 00851920007088 Catalog Number : 01-02-1003

Device Description : The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

740 SELECT - 00851920007095 Catalog Number : 01-02-1004

Device Description : The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic

Device Class : 2

Duns Number: 848429929

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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