CAMNTECH LIMITED

CAMNTECH LIMITED

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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

Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (5) Conditioner, Signal, Physiological (GWK) (3) Device, Sleep Assessment (LEL) (2)

Premarket Exempt

No

Clear

Actiheart - B329AH420 Catalog Number : 08-305

Device Description : Ambulatory ECG recorder with acclerometer - single channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : GWK

Prescription Use : Yes

Device Count : 1

Actiheart - B329AH556 Catalog Number : 18-500

Device Description : Ambulatory ECG recorder with acclerometer - single channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : GWK

Prescription Use : Yes

Device Count : 1

Actiheart - B329AHBT56 Catalog Number : 18-505

Device Description : Ambulatory ECG recorder with acclerometer - single channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : GWK

Prescription Use : Yes

Device Count : 1

Actiwave - B329AWV01E22 Catalog Number : 08-514

Device Description : Ambulatory ECG/EEG recorder - single channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Actiwave - B329AWV02E25 Catalog Number : 08-521

Device Description : Ambulatory ECG/EEG recorder - two channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Actiwave - B329AWV02M25 Catalog Number : 08-536

Device Description : Ambulatory Electromyogram (EMG) - two channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Actiwave - B329AWV04E22 Catalog Number : 08-557

Device Description : Ambulatory ECG/EEG recorder - four channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Actiwave - B329AWVC23 Catalog Number : 08-603

Device Description : Ambulatory ECG recorder with accelerometer - single channel

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Actiwave - B329AWVM33 Catalog Number : 08-565

Device Description : Ambulatory Accelerometry recorder - triaxial

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : LEL

Prescription Use : Yes

Device Count : 1

MotionWatch - B329MW850 Catalog Number : 04-111

Device Description : Ambulatory Physical Activity Recorder

Device Class : 2

Duns Number: 399114941

Premarket Exempt : No

Product Code : LEL

Prescription Use : Yes

Device Count : 1

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