Zephyr Sleep Technologies Inc

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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

Closed Loop Auto Titration Device For Oral Appliances (QCJ) (3) Device, Anti-Snoring (LRK) (3) Ventilatory Effort Recorder (MNR) (3)

Premarket Exempt

Clear

MATRx plus - B406CAT024010 Catalog Number :

Device Class : 2

Duns Number: 245252833

Premarket Exempt : No

Product Code : QCJ, MNR

Prescription Use : Yes

Device Count : 1

MATRx plus - B406CAT024020 Catalog Number :

Device Class : 2

Duns Number: 245252833

Premarket Exempt : No

Product Code : QCJ, MNR

Prescription Use : Yes

Device Count : 1

MATRx Plus - B406CAT024030 Catalog Number :

Device Class : 2

Duns Number: 245252833

Premarket Exempt : No

Product Code : QCJ, MNR

Prescription Use : Yes

Device Count : 1

TD Clip - B406CAT038020 Catalog Number : CAT-038-02

Device Class : 2

Duns Number: 245252833

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

TD Clip - B406CAT039020 Catalog Number : CAT-039-02

Device Class : 2

Duns Number: 245252833

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Remotely controlled mandibular positioner (MATRx) - B406CKT000000300100 Catalog Number :

Device Class : 2

Duns Number: 245252833

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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