RESMED CORP.

Address:600 Riverside Parkway Suite 100,Lithia Spgs,GA,30122,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

Ventilator, Non-Continuous (Respirator) (BZD) (5) Ventilator, Continuous, Facility Use (CBK) (1) Ventilator, Continuous, Non-Life-Supporting (MNS) (1) Ventilatory Effort Recorder (MNR) (1)

Premarket Exempt

Clear

RMDpulse - 00840193400023 Catalog Number :

Device Description : RMDpulse (Android)

Device Class : 2

Duns Number: 080243150

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

RMDpulse - 00840193400030 Catalog Number :

Device Description : RMDpulse (iOS)

Device Class : 2

Duns Number: 080243150

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirView - 00840193400108 Catalog Number : 22240

Device Description : AirView

Device Class : 2

Duns Number: 080243150

Premarket Exempt : No

Product Code : MNS, MNR, CBK, BZD

Prescription Use : Yes

Device Count : 1

myAir - 00840193400115 Catalog Number : 22245

Device Description : myAir (iOS)

Device Class : 2

Duns Number: 080243150

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

myAir - 00840193400122 Catalog Number : 22246

Device Description : myAir (Android)

Device Class : 2

Duns Number: 080243150

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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