Radiometer Medical ApS

Address:AAKANDEVEJ 21,BROENSHOEJ Hovedstaden,DK

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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, oxygen, cutaneous, for uses other than for infant not under gas anesthesia (LPP) (10) MONITOR, CARBON-DIOXIDE, CUTANEOUS (LKD) (9) Monitor, oxygen, cutaneous, for infant not under gas anesthesia (KLK) (9) Oximeter (DQA) (9) Oximeter, ear (DPZ) (5)

Premarket Exempt

Clear

TCM TOSCA module - 05700699030443 Catalog Number : 903-044

Device Description : TCM TOSCA module

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, DQA, DPZ, KLK, LPP

Prescription Use : Yes

Device Count : 1

TCM CombiM module - 05700699031112 Catalog Number : 903-111

Device Description : TCM CombiM module

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : DQA, LKD, KLK, LPP, DPZ

Prescription Use : Yes

Device Count : 1

TCM4x Cable - 05700699031808 Catalog Number : 903-180

Device Description : TCM4x Alice Int interface cable. Connecting cable to an external device (PSG)

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, KLK, LPP, DQA, DPZ

Prescription Use : Yes

Device Count : 1

TCM4x Cable - 05700699031815 Catalog Number : 903-181

Device Description : TCM4x Embletta gold interface cable

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, KLK, DQA, DPZ, LPP

Prescription Use : Yes

Device Count : 1

TCM4x Cable - 05700699031822 Catalog Number : 903-182

Device Description : TCM4x Embla interface cable

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, LPP, DPZ, DQA, KLK

Prescription Use : Yes

Device Count : 1

TCM4x Cable - 05700699033390 Catalog Number : 903-339

Device Description : TCM4x Embla MDrive interface cable. Connecting cable to an externa device (PSG).

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, DQA, LPP, KLK

Prescription Use : Yes

Device Count : 1

TCM4x Cable - 05700699033406 Catalog Number : 903-340

Device Description : TCM4x Alice DE interface cable. Connecting cable to an external device (PSG).

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, DQA, LPP, KLK

Prescription Use : Yes

Device Count : 1

TC electrode - 05700699043085 Catalog Number : 904-308

Device Description : D826 Accessory kit for TC pO2 electrode

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LPP

Prescription Use : Yes

Device Count : 1

Fixation Kit For TC electrodes - 05700699048912 Catalog Number : 904-891

Device Description : D282 Fixation kit For TC electrodes

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LPP, LKD, KLK, DQA

Prescription Use : Yes

Device Count : 1

TC pO2/pCO2 Membraning kit For TC electrode - 05700699048929 Catalog Number : 904-892

Device Description : D280 Membraning kit For TC pO2/pCO2 electrode

Device Class : 2

Duns Number: 308667539

Premarket Exempt : No

Product Code : LKD, KLK, LPP, DQA

Prescription Use : Yes

Device Count : 1

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