AMPLION CLINICAL COMMUNICATIONS, INC.

Address:632 Melrose Ave,Nashville,TN,37211,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

System, Environmental Control, Powered (IQA) (10)

Premarket Exempt

Yes

Clear

Amplion Care Assurance - 00850016398406 Catalog Number : F-CAS-288A-1

Device Description : Firmware for Care Assurance Station (CAS), Version 288A

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398413 Catalog Number : F-CPS-B1BF-1

Device Description : Firmware for Code Pink Station (CPS), Version B1BF

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398420 Catalog Number : F-SL-4A86-1

Device Description : Firmware for Smart Light (SL) and Zone Light (ZL), Version 4A86

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398437 Catalog Number : F-SL-63d6c96-1

Device Description : Bootloader Firmware for Smart Light (SL) and Zone Light (ZL)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398444 Catalog Number : F-DS-81B5-1

Device Description : Firmware for Duty Station (DS), Version 81B5

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398451 Catalog Number : F-DS-F886-1

Device Description : Firmware for Duty Station (DS), Version F886

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398468 Catalog Number : F-ES-C80A-1

Device Description : Firmware for Emergency Station (ES), Version C80A

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398475 Catalog Number : F-CAS-63d6c96-1

Device Description : Bootloader Firmware for Code Blue Station (CBS), Code Pink Station (CPS), Shower Bootloader Firmware for Code Blue Station (CBS), Code Pink Station (CPS), Shower Station (SHS), Toilet Station (TS), Care Assurance Station (CAS), Duty Station (DS), Emergency Station (ES)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398482 Catalog Number : F-PAS-5730-1

Device Description : Firmware for Patient Station (PAS), Version 5730

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398499 Catalog Number : F-PAS-63d6c96-1

Device Description : Bootloader Firmware for Patient Station (PAS)

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

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