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Sign in to claim this brandFLUKE ELECTRONICS CORPORATION
US
Last updated May 24, 2026
What FLUKE ELECTRONICS CORPORATION makes
Fluké Electronics Corporation manufactures devices for testing and simulating medical equipment, including multi-parameter testers for electrical safety and defibrillator functionality, as well as noninvasive blood pressure simulators and air/gas pressure transducers. Their product line also includes external defibrillator testers and blood pressure pump simulators designed for calibration and training purposes.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identification (UDI) database. The company operates from the United States, adhering to applicable medical device regulations in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Fluké Electronics Corporation manufacture?
Fluké Electronics Corporation specializes in devices that test, simulate, and calibrate medical equipment. Their most common products include multi-parameter testers for electrical safety and defibrillator functionality, electrical safety testers, external defibrillator testers, noninvasive blood pressure physical simulators, and air/gas pressure transducers. These devices are designed to ensure medical equipment performs as intended, whether for training, maintenance, or regulatory compliance.
Where is Fluké Electronics Corporation based?
Fluké Electronics Corporation is headquartered in the United States. As a manufacturer of medical devices, their operations are subject to U.S. regulatory requirements, including those governing device safety, performance, and compliance with standards like Class II classification.
Are Fluké Electronics Corporation’s devices listed in any regulatory registries?
Yes, Fluké Electronics Corporation’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices through standardized identifiers, ensuring transparency in the supply chain and aiding in regulatory oversight, recalls, or post-market surveillance.
How are Fluké Electronics Corporation’s devices classified under regulatory frameworks?
Fluké Electronics Corporation’s devices fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. Class II devices undergo rigorous evaluation to balance innovation with patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 002687614
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Esa 620 | ESA620 | FDA UDI | Class II | Active |
| SigmaPace 1000 | SIGMAP1K-USA120V | FDA UDI | Class II | Active |
| ProSim 4 | PROSIM 4 | FDA UDI | Class II | Active |
| Esa 612 | ESA612-US | FDA UDI | Class II | Active |
| ProSim 3 | PROSIM 3 | FDA UDI | Class II | Active |
| Impulse 7000DP | IMPULSE 7000DP | FDA UDI | Class II | Active |
| Esa 612 | ESA612-10-NA220 | FDA UDI | Class II | Active |
| BP Pump 2L | BPPUMP2L-US120V | FDA UDI | Class II | Active |
| ProSim SPOT Light | SPOT LIGHT | FDA UDI | Class II | Active |
| BP Pump 2M | BPPUMP2M-US120V | FDA UDI | Class II | Active |
| Esa 614 | ESA614 | FDA UDI | Class II | Active |
| Impulse 7010 | IMPULSE 7010 | FDA UDI | Class II | Active |
| Ps320 | PS320 | FDA UDI | Class II | Active |
| Impulse 6000D | IMPULSE 6000D | FDA UDI | Class II | Active |
| Impulse 4000 | IMPULSE4K-USA120V | FDA UDI | Class II | Active |
| Esa 615 | ESA615-US | FDA UDI | Class II | Active |
| Dpm1b | DPM1B | FDA UDI | Class II | Active |
| ProSim 8 | PROSIM 8 | FDA UDI | Class II | Active |
| Ps410 | PS410 | FDA UDI | Class II | Active |
| ProSim 8P | PROSIM 8P | FDA UDI | Class II | Active |
| Esa 615 | ESA615-10-NA220 | FDA UDI | Class II | Active |
| ProSim 2 | PROSIM 2 | FDA UDI | Class II | Active |
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