Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K982025 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

ST

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• What types of clinical settings is the Hewlett-Packard M2475B With 12-Lead Option intended for use in, and who should operate it?

  The Hewlett-Packard M2475B With 12-Lead Option is designed for use in clinical environments, such as hospitals or emergency care settings, where trained personnel—like nurses, paramedics, or physicians—can administer it under physician-approved protocols. Its advanced features, including 12-lead ECG capability, support acute cardiac assessment, making it ideal for emergency response teams and critical care units.

• Is the device single-use or reusable, and what maintenance does it require?

  The Hewlett-Packard M2475B is a reusable medical device, meaning it is intended for repeated use in clinical settings. To ensure reliable performance, it requires proper maintenance and calibration as outlined in the manufacturer’s guidelines. Regular upkeep is essential to sustain its functionality for synchronized cardioversion, defibrillation, and continuous patient monitoring.

• Does this defibrillator include advanced diagnostic capabilities, and if so, how does that benefit clinicians?

  Yes, the M2475B With 12-Lead Option includes 12-lead ECG capability, allowing clinicians to assess cardiac rhythms and diagnose acute coronary syndromes. This feature aids in making informed clinical decisions quickly, particularly in emergency situations where rapid diagnosis and treatment are critical.

• What storage requirements should be followed to maintain the device’s operational integrity?

  The device must be stored in accordance with the manufacturer’s instructions to ensure it remains operational. While specific storage conditions (like temperature or environmental controls) aren’t detailed here, adhering to Hewlett-Packard’s guidelines—likely including protection from extreme conditions—will help preserve its performance for synchronized cardioversion, defibrillation, and monitoring functions.

• Is this device compatible with MRI environments, and what precautions should be taken during use?

  The Hewlett-Packard M2475B is explicitly not MRI-compatible, meaning it should never be used or stored near MRI machines. Since defibrillators like this rely on electromagnetic functionality, exposure to MRI fields could compromise its operation or pose safety risks. Always follow manufacturer guidelines for safe handling and placement in clinical areas.