INTELLIGENT HEARING SYSTEMS CORP.

Address:6860 S.W. 81ST ST.,MIAMI,FL,33143,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

Audiometer (EWO) (6) Stimulator, Auditory, Evoked Response (GWJ) (1)

Premarket Exempt

No Yes

Clear

DD45-300 Headphones - 00817020021065 Catalog Number :

Device Class : 2

Duns Number: 154870455

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : Yes

Device Count : 1

MADSEN Capella2 DP - 00817020029900 Catalog Number :

Device Class : 2

Duns Number: 154870455

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

MADSEN Capella2 TE - 00817020029917 Catalog Number :

Device Class : 2

Duns Number: 154870455

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

MADSEN Capella2 DP+TE - 00817020029924 Catalog Number :

Device Class : 2

Duns Number: 154870455

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

Capella2 Starter Kit - 00817020029931 Catalog Number :

Device Class : 2

Duns Number: 154870455

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

EarHugs for AccuScreen - 00817020029948 Catalog Number :

Device Class : 2

Duns Number: 154870455

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

OAE 10D Probe - 00817020029993 Catalog Number :

Device Description : OAE 10D Probe with calibration thumbdrive

Device Class : 2

Duns Number: 154870455

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

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