EXERGEN CORPORATION

EXERGEN CORPORATION

Address:400 PLEASANT STREET,Watertown,MA,02472,US

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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

Thermometer, Electronic, Clinical (FLL) (10)

Premarket Exempt

No

Clear

Exergen Temporal Scanner - 00834098002062 Catalog Number : 140008

Device Description : TAT2000C Temporal Scanner

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 00834098002109 Catalog Number : 140010, 140022, 144010, 140019, 144035, 144056, 144061, 144065, 144070, 140061

Device Description : TAT2000C Temporal Scanner

Device Class :

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 00834098002314 Catalog Number : 144051, 140018, 144018, 144019, 140021, 140026, 144044, 144051

Device Description : TAT2000C Temporal Scanner

Device Class :

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 00834098002918 Catalog Number : 140050, 144060, 140033

Device Description : TAT2000C Original Temporal Scanner

Device Class :

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 00834098002925 Catalog Number : 140055, 144052

Device Description : TAT2000C Temporal Scanner

Device Class :

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 00834098002949 Catalog Number : 140080, 144080

Device Description : TAT2000C Temporal Scanner

Device Class :

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 00834098002956 Catalog Number : 140072, 144072, 140075, 144075, 140100

Device Description : TAT2000C Temporal Scanner

Device Class :

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000089 Catalog Number : 124275, 124276, 124275-R, 124276-R

Device Description : TAT5000 Arterial Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000102 Catalog Number : 124375, 124374, 124375-R

Device Description : TAT5000 Oral Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Exergen Temporal Scanner - 10834098000126 Catalog Number : 124279, 124277, 124286, 124288, 124290, 124292, 124294, 124279-R, 124279-RC

Device Description : TAT5000 Quick Release Arterial Calibration

Device Class : 2

Duns Number: 061266060

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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