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 Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

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 Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea.

Device Class : 2

Duns Number: 059636679

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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