PREVOUNCE HEALTH, LLC

Address:3250 N Post Road,Indianapolis,IN,46226,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, Measurement, Blood-Pressure, Non-Invasive (DXN) (4) Scale, Stand-On, Patient (FRI) (1)

Premarket Exempt

No Yes

Clear

Pylo Health - 00860004709503 Catalog Number :

Device Description : Cellular connected (Cat-M) non-invasive blood pressure monitor.

Device Class :

Duns Number: 116961530

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Pylo Health - 00860004709510 Catalog Number :

Device Description : Cellular connected (LTE) body weight scale for remote patient monitoring.

Device Class : 1

Duns Number: 116961530

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

Pylo Health - 00860004709527 Catalog Number :

Device Description : Non-invasive digital blood pressure monitor.

Device Class : 2

Duns Number: 116961530

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Pylo Health - 00860004709534 Catalog Number :

Device Description : Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.

Device Class : 2

Duns Number: 116961530

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Pylo Health - 00860004709565 Catalog Number :

Device Description : Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.

Device Class : 2

Duns Number: 116961530

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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