Arjohuntleigh AB

Address:HANS MICHELSENSGATAN 10,MALMO Skane,SE

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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

Mattress, Flotation Therapy, Non-Powered (IKY) (8) Mattress, Air Flotation, Alternating Pressure (FNM) (2)

Premarket Exempt

Yes No

Clear

AtmosAir 9000X - 05059441150039 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 880 X 2020 X 180 mm (35 X 80 X 7 in) - Top Cover Reliant

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150046 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 880 X 2020 X 180 mm (35 X 80 X 7 in) - Top Cover Premium

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150053 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 880 X 2140 X 180 mm (35 X 84 X 7 in) - Top Cover Reliant

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150060 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 880 X 2140 X 180 mm (35 X 84 X 7 in) - Top Cover Premium

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150077 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 880 X 2000 X 180 mm (35 X 79 X 7 in) - Top Cover Reliant

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150084 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 880 X 2000 X 180 mm (35 X 79 X 7 in) - Top Cover Premium

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150091 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 1070 X 2000 X 180 mm (42 X 79 X 7 in) - Top Co AtmosAir 9000X Hybrid mattress - 1070 X 2000 X 180 mm (42 X 79 X 7 in) - Top Cover Reliant

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir 9000X - 05059441150107 Catalog Number :

Device Description : AtmosAir 9000X Hybrid mattress - 1070 X 2000 X 180 mm (42 X 79 X 7 in) - Top Co AtmosAir 9000X Hybrid mattress - 1070 X 2000 X 180 mm (42 X 79 X 7 in) - Top Cover Premium

Device Class : 1

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

AtmosAir Velaris - 05059441150114 Catalog Number :

Device Description : AtmosAir Velaris Mattress - Stretcher - 670 x 1950 x 130 mm (26 x 77 x 5 in) - AtmosAir Velaris Mattress - Stretcher - 670 x 1950 x 130 mm (26 x 77 x 5 in) - Top Cover Reliant

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

AtmosAir Velaris - 05059441150121 Catalog Number :

Device Description : AtmosAir Velaris Mattress - Stretcher - 670 x 1950 x 130 mm (26 x 77 x 5 in) - AtmosAir Velaris Mattress - Stretcher - 670 x 1950 x 130 mm (26 x 77 x 5 in) - Top Cover Premium

Device Class : 2

Duns Number: 355804758

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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