DIACOR, INC.

Address:2550 DECKER LAKE BLVD.,West Valley City,UT,84119,US

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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

Device, Patient Transfer, Powered (FRZ) (6) Stretcher, Wheeled (FPO) (4)

Premarket Exempt

No Yes

Clear

Zephyr Patient Positioning and Transfer System - B237ZEPAUB510 Catalog Number :

Device Description : Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp - 3 sc Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp - 3 screw mount design

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAUB520 Catalog Number :

Device Description : Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 2 screw mount design

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAUB530 Catalog Number :

Device Description : Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 3 screw mount design

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAUB600 Catalog Number :

Device Description : Zephyr HDR Accessory - Universal Clamp Bracket for Varian Universal Clamp

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAUB610 Catalog Number :

Device Description : Zephyr HDR Accessory - Universal Clamp Bracket for Varian Universal Clamp (Rev2)

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAUB700 Catalog Number :

Device Description : Zephyr HDR Accessory - Universal Clamp Bracket for RPD Universal Clamp

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Stretcher - B237ZTG20 Catalog Number :

Device Description : Zephyr MR Conditional Stretcher

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : Yes

Device Count : 1

Zephyr Patient Stretcher - B237ZTG40 Catalog Number :

Device Description : Zephyr Patient Stretcher

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : Yes

Device Count : 1

Zephyr Patient Stretcher - B237ZTGACA010 Catalog Number :

Device Description : Zephyr Stretcher Accessory - C-Arm Extension Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : Yes

Device Count : 1

Zephyr Patient Stretcher - B237ZTGAIB010 Catalog Number :

Device Description : Zephyr Procedural Stretcher Accessory - Dräger Mobile Anesthesia Interface Bar

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : Yes

Device Count : 1

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