FLUKE ELECTRONICS CORPORATION

FLUKE ELECTRONICS CORPORATION

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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, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (10)

Premarket Exempt

No

Clear

ESA 620 - 00850540007010 Catalog Number : 2785725

Device Description : Electrical Safety Analyzer

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ESA 615 - 00850540007027 Catalog Number : 4132046

Device Description : Electrical Safety Analyzer

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ESA 615 - 00850540007034 Catalog Number : 4132164

Device Description : Electrical Safety Analyzer

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ESA 612 - 00850540007041 Catalog Number : 4132173

Device Description : Electrical Safety Analyzer

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ESA 612 - 00850540007058 Catalog Number : 4132260

Device Description : Electrical Safety Analyzer

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ProSim 8 - 00850540007065 Catalog Number : 3979409

Device Description : Vital Signs Patient Simulator

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ProSim 4 - 00850540007072 Catalog Number : 3985156

Device Description : Vital Signs Patient Simulator

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ProSim 2 - 00850540007089 Catalog Number : 4318341

Device Description : Vital Signs Patient Simulator

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ProSim 3 - 00850540007096 Catalog Number : 4307790

Device Description : Vital Signs Patient Simulator

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

ProSim SPOT Light - 00850540007102 Catalog Number : 4111101

Device Description : SpO2 Pulse Oximeter Analyzer

Device Class : 2

Duns Number: 002687614

Premarket Exempt : No

Product Code : DRT

Prescription Use : No

Device Count : 1

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