UC-CARE LTD

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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, Image Processing, Radiological (LLZ) (10)

Premarket Exempt

Clear

Navigo™ Workstation - 07290016936001 Catalog Number : FPRMC0016A

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Computer (Industrial) - 07290016936018 Catalog Number : FPRCO00011

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for BK 8808 (square) - 07290016936025 Catalog Number : FPRSA00006

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for BK 8818 and 8808e (square) - 07290016936032 Catalog Number : FPRSA00007

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for Hitachi V53W (square) - 07290016936049 Catalog Number : FPRSA00008

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for GE E8CS (square) - 07290016936056 Catalog Number : FPRSA00009

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for BK 8667 (square) - 07290016936063 Catalog Number : FPRSA00011

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for MindRay - 07290016936070 Catalog Number : FPRSA00013

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for GE E8CS - 07290016936087 Catalog Number : FPRSA00014

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor assembly for Hitachi V53W - 07290016936094 Catalog Number : FPRSA00012

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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