RESPIRE MEDICAL HOLDINGS LLC

Address:3958 Valley Avenue, Suite H,Pleasanton,CA,94566,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, Anti-Snoring (LRK) (10)

Premarket Exempt

Clear

Blue Series - H/S - 00851861007000 Catalog Number :

Device Description : Respire Blue Series (Hard/Soft)

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Blue Series - Hard - 00851861007017 Catalog Number :

Device Description : Respire Blue Series - Hard

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Blue Series - EF - 00851861007024 Catalog Number :

Device Description : Respire Blue Series EF

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Pink Micro - Hard - 00851861007031 Catalog Number :

Device Description : Respire Pink (Herbst) Micro - Hard

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Pink Micro - H/S - 00851861007048 Catalog Number :

Device Description : Respire Pink Micro (Herbst) Hard/Soft

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Pink Micro - EF - 00851861007055 Catalog Number :

Device Description : Respire Pink Micro (Herbst) EF

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Pink Series - EF - 00851861007062 Catalog Number :

Device Description : Respire Pink Series (Herbst) - EF

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Pink Series - H/S - 00851861007079 Catalog Number :

Device Description : Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Pink Series - Hard - 00851861007086 Catalog Number :

Device Description : Respire Pink Series (Herbst) - Hard

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Blue + Hard - 00851861007093 Catalog Number :

Device Description : Intraoral appliance for the treatment of snoring and mild to moderate obstructiv

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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