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 - 00850016398307 Catalog Number : D-TS-13-1

Device Description : Toilet Station (TS), Version 1.3

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398314 Catalog Number : D-ZC-12-1

Device Description : Zone Controller (ZC), Version 1.2

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398321 Catalog Number : D-ZL-11-1

Device Description : Zone Light (ZL), Version 1.1

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398338 Catalog Number : S-APP-238-1

Device Description : Amplion phone application for the Android OS system used on smartphones, Version 2.3.8

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398345 Catalog Number : S-CBA-187-1

Device Description : Software for Code Blue Annunciator, Version 1.8.7

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398352 Catalog Number : S-MGC-187-1

Device Description : Software for Messaging Controller, Version 1.8.7

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398369 Catalog Number : S-NCC-187-1

Device Description : Software for Nurse Call Controller & Nurse Call Web Directory, Version 1.8.7

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398376 Catalog Number : S-NCC-187-2

Device Description : Software for Nurse Call Controller and Nurse Call Web Directory, Version 1.8.7, Software for Nurse Call Controller and Nurse Call Web Directory, Version 1.8.7, with additional configuration for BIS Nurse Call and Heartbeat

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398383 Catalog Number : S-NSC-2200-1

Device Description : Software for Nurse Station Console, Version 2.2.0.0

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

Amplion Care Assurance - 00850016398390 Catalog Number : S-SRC-187-1

Device Description : Software for Smart Room Controller, Version 1.8.7

Device Class : 2

Duns Number: 626493555

Premarket Exempt : Yes

Product Code : IQA

Prescription Use : No

Device Count : 1

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