FDA Registration Active 🇬🇧 United Kingdom

PLT-705BTH PLT-1204BT PC-20M PLT-705BTF PLT-1204AX PC-50M PLT-805AT PLT- 1204BX

Reg #: 3013204397 · FEI: 3013204397 · Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Modality Group Ltd
Registration Number
3013204397
FEI Number
3013204397
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Unit 56 Hayhill Industrial Estate, 47 Hayhill
City
Barrow upon Soar Leicestershire
Country
GB

Regulatory Submissions

510(k) Number
K091295

Owner / Operator

Firm Name
Modality Group Ltd
Operator Number
10053163
Address
Fosse House, 20 Prince William Road
City
Loughborough
State
Leicestershire
Postal Code
LE11 5GU
Country
GB
Correspondent
Carl Bowtell

Products

Device Name Product Code
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX

Proprietary Names

PLT-705BTH PLT-1204BT PC-20M PLT-705BTF PLT-1204AX PC-50M PLT-805AT PLT- 1204BX PVT-770RT PVT-375BT PVT-674BT PLT-604AT PLT-704AT PLT-1202S PLT-1204MV PLT-704SBT PLT-1204AT PET-5 10MB Aplio XG, PST-25BT PVT-375MV PVT 661VT PST-30BT PET-382BT PVT-681MV PST-50AT PVT-382MV PVT-745BTV PST-65AT PVT-575MV

Establishment Types

Export Device to the United States But Perform No Other Operation on Device