AMBIENT CLINICAL ANALYTICS, INC.

Address:221 1st Ave SW,Rochester,MN,55902,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

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (3) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (1)

Premarket Exempt

Clear

AWARE - 00850893007002 Catalog Number :

Device Class : 2

Duns Number: 080221585

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

AWARE - 00850893007019 Catalog Number :

Device Description : Clinical decision support software indicated for use by licensed clinicians in a Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA product.

Device Class : 2

Duns Number: 080221585

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

AWARE DART - 00850893007026 Catalog Number :

Device Description : Clinical decision support software for disease detection and response indicated Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.

Device Class : 2

Duns Number: 080221585

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

AWARE DART iOS Client - 00850893007033 Catalog Number :

Device Description : Clinical decision support software indicated for use by licensed clinicians to i Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.

Device Class : 2

Duns Number: 080221585

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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