NFANT LABS LLC

Address:1930 ARPT IND PK DR SE UNIT G,Marietta,GA,30060,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

Device, Biofeedback (HCC) (4)

Premarket Exempt

Clear

nfant® Patient Database - 00861410000208 Catalog Number : ND3

Device Class : 2

Duns Number: 080007197

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

nfant® SSB Sensor - 00861410000215 Catalog Number : NS1

Device Class : 2

Duns Number: 080007197

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

nfant® Coupling - 00861410000239 Catalog Number : NC2-1

Device Class :

Duns Number: 080007197

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

nfant® Mobile App - 00861410000246 Catalog Number : NA4

Device Class : 2

Duns Number: 080007197

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

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