AMTAI MEDICAL EQUIPMENT, INC.

Address:5605 PRIMAVERA CT,Raleigh,NC,27616,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

Light, Surgical, Ceiling Mounted (FSY) (3) Table, Operating-Room, Ac-Powered (FQO) (1)

Premarket Exempt

Yes

Clear

AMTAI - 00811889032156 Catalog Number :

Device Description : Surgical Light (TM), Lamp R625+R725, 220V

Device Class : 2

Duns Number: 830186198

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

AMTAI - 00811889032163 Catalog Number :

Device Description : Surgical Light (PM), Camera-ready Lamp R625+R725, 220V

Device Class : 2

Duns Number: 830186198

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

AMTAI - 00811889032170 Catalog Number :

Device Description : Surgical Light (PM), Lamp R625+LCD Spring Arm, 110V

Device Class : 2

Duns Number: 830186198

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : No

Device Count : 1

AMTAI - 00811889032187 Catalog Number :

Device Description : Pad for Horizontal Leg Support

Device Class : 1

Duns Number: 830186198

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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