VITALOGRAPH (IRELAND) LIMITED

Address:Gort Road Business Park,Co Clare,IE

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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

CALIBRATOR, VOLUME, GAS (BXW) (5) SPIROMETER, DIAGNOSTIC (BZG) (4) METER, PEAK FLOW, SPIROMETRY (BZH) (1)

Premarket Exempt

No Yes

Clear

PFM - 05099169439818 Catalog Number :

Device Description : 4300 PEAK FLOW METER

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

PFM - 05099169439832 Catalog Number :

Device Description : 4300 PEAK FLOW METER myPEF SWITZERLAND

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BXW

Prescription Use : No

Device Count : 1

PFM - 05099169439849 Catalog Number :

Device Description : 4300 PEAK FLOW METER myPEF

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BXW

Prescription Use : No

Device Count : 1

PFM - 05099169439917 Catalog Number :

Device Description : 4300 PEAK FLOW METER

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BXW

Prescription Use : No

Device Count : 1

PFM - 05099169439931 Catalog Number :

Device Description : 4300 PEAK FLOW METER myPEF

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BXW

Prescription Use : No

Device Count : 1

PFM - 05099169439979 Catalog Number :

Device Description : 4300 PEAK FLOW METER myPEF

Device Class :

Duns Number: 219683489

Premarket Exempt : No

Product Code : BXW

Prescription Use : No

Device Count : 1

Pneumotrac - 05099169770010 Catalog Number :

Device Description : 6800 PNEUMOTRAC USA

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Pneumotrac - 05099169777019 Catalog Number :

Device Description : MODEL 6800 PNEUMOTRAC US(1)

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Pneumotrac - 05099169777330 Catalog Number :

Device Description : MODEL 6800 INTRAC(1)

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

In2itive - 05099169790018 Catalog Number :

Device Description : CASE 2120 HAND HELD VITALOGRAPH IN2ITIVE US (1)

Device Class : 2

Duns Number: 219683489

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

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