INVIVO CORPORATION

Address:3545 SW 47th Ave,GAINESVILLE,FL,32608,US

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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

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) (DSA) (3) Oximeter (DQA) (3) MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) (MWI) (2) Monitor, physiological, patient (without arrhythmia detection or alarms) (MWI) (1) Thermometer, electronic, clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

FiberTEMP Fiber Optic Surface Temperature Sensor - 00884838004979 Catalog Number : 989803152801

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

MR Patient Care Short Wide ECG 2.0 Cable AAMI - 00884838006379 Catalog Number : 9223

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

MR Patient Care Short Standard ECG 2.0 Cable AAMI - 00884838006386 Catalog Number : 9223

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

MR Patient Care Short Neonatal ECG 2.0 Cable AAMI - 00884838006393 Catalog Number : 9222

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Essential MRI Patient Monitor (Model 865353) - 00884838012585 Catalog Number : 865353

Device Description : Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) i Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI environment. Key Features include: Communicates wirelessly with Invivo. Expression or Precess 2nd-Gen wSpO2 Modules for seamless patient transitions, Touch Screen Display Unrestricted MRI Gauss Rating, Lightweight portable Alarm light All parameters support Adult, Pediatric, infant and Neonatal applications,8-Hour Smart Battery Technology, Environmentally friendly Green, Flexible mounting options. One (1) year limited warranty and factory service for hardware

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MR Patient Care Adult SpO2 Clip - 00884838012592 Catalog Number : 989803166531

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MR Patient Care Pediatric SpO2 Clip - 00884838012608 Catalog Number : 989803166541

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

NA - 00884838014602 Catalog Number : 452230032811

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

NA - 00884838014695 Catalog Number : 452230032863

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

NA - 00884838014732 Catalog Number : 452230032261

Device Class : 2

Duns Number: 013649151

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

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