IVY BIOMEDICAL SYSTEMS, INC.

Address:11 BUSINESS PARK DR.,Branford,CT,06405,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

System, Nuclear Magnetic Resonance Imaging (LNH) (10) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (2)

Premarket Exempt

No Yes

Clear

PPG Finger Band - 00816396022805 Catalog Number :

Device Description : PPG Finger Band

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023116 Catalog Number :

Device Description : WGS-100 Transmitter

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023123 Catalog Number :

Device Description : WGS-100 Transmitter

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023130 Catalog Number :

Device Description : WGS-100 Base Station

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023147 Catalog Number :

Device Description : WGS-100 Base Station

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023154 Catalog Number :

Device Description : WGS-100 Charging Station

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023161 Catalog Number :

Device Description : WGS-100 Charging Station

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

MRI ECG Cable - 00816396023239 Catalog Number :

Device Description : MRI ECG Cable

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : MWI, LNH

Prescription Use : No

Device Count : 1

MRI ECG Cable - 00816396023246 Catalog Number :

Device Description : MRI ECG Cable

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : MWI, LNH

Prescription Use : No

Device Count : 1

WGS-100 - 00816396023253 Catalog Number :

Device Description : WGS-100 Wireless Gating System

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

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