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

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (10)

Premarket Exempt

No Yes

Clear

Model 7600 - 00816396020306 Catalog Number : 3303-35-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020313 Catalog Number : 3303-36-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020320 Catalog Number : 3303-37-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020337 Catalog Number : 3303-38-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020344 Catalog Number : 3303-39-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020351 Catalog Number : 3303-40-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020368 Catalog Number : 3303-41-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7600 - 00816396020375 Catalog Number : 3303-42-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7700 - 00816396020382 Catalog Number : 3607-00-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

Model 7700 - 00816396020399 Catalog Number : 3607-01-15

Device Description : Cardiac Gating Monitor & Accessory Kit

Device Class : 2

Duns Number: 109132019

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

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