RESPIRATORY MOTION INC.

Address:80 Coolidge Hill Rd,Watertown,MA,02472,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

Monitor, Breathing Frequency (BZQ) (6) Spirometer, Monitoring (W/Wo Alarm) (BZK) (6)

Premarket Exempt

No Yes

Clear

ExSpiron 1Xi - 00851540007000 Catalog Number : RMI-51000

Device Description : A noninvasive device designed to continuously measure a patient's tidal volume,

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZK, BZQ

Prescription Use : Yes

Device Count : 1

ExSpiron 1Xi - 00851540007017 Catalog Number : RMI-51130

Device Description : Noninvasive, insulated, electrical cable designed to connect the ExSpiron 1Xi Mo

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

ExSpiron 1Xi - 00851540007024 Catalog Number : RMI-51250

Device Description : Insulated, reusable, medical grade electrical cord design to enable connection o

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : No

Device Count : 1

ExSpiron 1Xi - 00851540007048 Catalog Number : RMI-51110

Device Description : A non-sterile, single use electrode set designed to be adhered across a patient'

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

ExSpiron 1Xi - 00851540007055 Catalog Number : RMI-51155

Device Description : Assembly designed to be integrated into medical facility infrastructure in order

Device Class :

Duns Number: 963613745

Premarket Exempt : Yes

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

ExSpiron 2Xi - 00851540007147 Catalog Number :

Device Description : A noninvasive device designed to continuously measure a patient's tidal volume,

Device Class :

Duns Number: 963613745

Premarket Exempt : No

Product Code : BZQ, BZK

Prescription Use : Yes

Device Count : 1

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