SKYTRON LLC

Address:5085 Corporate Exchange Blvd SE,Grand Rapids,MI,49512,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

TABLE, OPERATING-ROOM, AC-POWERED (FQO) (10)

Premarket Exempt

No Yes

Clear

Skytron - 10841736122980 Catalog Number : 5-010-22-3B-C1

Device Description : 3600 TOP SECTION CUSTOM EXTENDED LENGTH X-RAY

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122997 Catalog Number : 5-010-22-B

Device Description : Radiographic top (3600B)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123000 Catalog Number : 5-010-23-1B

Device Description : X-RAY TOP HEAD SECTION (3501 6300)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123017 Catalog Number : 5-010-23-4B

Device Description : XRAY TOP FOOT/ LEG SECTION 3501B .375 X 19.685 X 22.83

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123024 Catalog Number : 5-010-23-B

Device Description : Radiographic top (3501C)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123031 Catalog Number : 5-010-26-B

Device Description : 1602 X-Ray Top Set

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123048 Catalog Number : 5-010-27-2B

Device Description : X-RAY TOP BACK SECTION 6300 SERIES : 3/8x18.23x19.685

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123055 Catalog Number : 5-010-27-3B

Device Description : X-RAY TOP SEAT SECTION 6300 SERIES : 3/8x15.47x19.685

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123062 Catalog Number : 5-010-27-4B

Device Description : X-RAY TOP FOOT/ LEG SECTION 6300 SERIES : 3/8x23.03x19.685

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123079 Catalog Number : 5-010-27-B

Device Description : Radiographic top (6300)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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