Bittium Biosignals Oy

Address:PIONEERINKATU 6,KUOPIO Pohjois-Savo,FI

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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

Electrode, Electrocardiograph (DRX) (6) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (3) Device, Biofeedback (HCC) (1)

Premarket Exempt

Yes No

Clear

ME6000 - 06430035220243 Catalog Number :

Device Description : ME6000 is a portable telemetry and data logger in measurement and monitoring of ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Faros 360 waterproof - 06430035220311 Catalog Number : 901159

Device Description : Device for 3-channel ECG and motion measurement, monitoring and data collection.

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Bittium Faros 180 waterproof - 06430035220328 Catalog Number :

Device Description : Device for 1-channel ECG and motion measurement, monitoring and data collection

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Fast-Fix ECG Electrode - 06430035220335 Catalog Number :

Device Description : The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's chest, and it transfers the hearts biosignal from the body to the Faros ECG device.

Device Class : 2

Duns Number: 369960000

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bittium Faros - 06430035220366 Catalog Number :

Device Description : Device for 3-channel ECG and motion measurement, monitoring and data collection

Device Class : 2

Duns Number: 369960000

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Bittium OmegaSnap - 06430035220519 Catalog Number : 9404644

Device Description : 1-CH ECG Electrode

Device Class : 2

Duns Number: 369960000

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bittium OmegaSnap - 06430035220588 Catalog Number : 9400147

Device Description : Bittium OmegaSnap 1-CH Adapter

Device Class : 2

Duns Number: 369960000

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bittium OmegaSnap - 06430035220670 Catalog Number : 9404716

Device Description : 2-CH ECG Electrode

Device Class : 2

Duns Number: 369960000

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bittium OmegaSnap - 06430035220687 Catalog Number : 9404717

Device Description : 3-CH ECG Electrode

Device Class : 2

Duns Number: 369960000

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bittium OmegaSnap - 06430035220694 Catalog Number : 9404718

Device Description : Bittium MiniSnap Sensitive 1-CH ECG Electrode

Device Class : 2

Duns Number: 369960000

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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