The Sierra II Bone Vibrator (Model 199224-200) by Cadwell Industries is a specialized accessory designed for auditory evoked potential (AEP) testing, particularly useful in audiology and neurophysiological diagnostics. This device facilitates bone conduction auditory stimulation, allowing clinicians to assess hearing pathways effectively.
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🔍 Key Specifications
Manufacturer: Cadwell Industries, Inc.
Model Number: 199224-200
Device Classification: Electromyograph (EMG) accessory
Commercial Status: In Commercial Distribution
FDA Device Identifier (DI): 00840067100547
Product Code (FDA): OLT
GMDN Term: Electromyograph
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⚙️ Functional Overview
The Sierra II Bone Vibrator is engineered to deliver precise vibratory stimuli to the mastoid bone, enabling bone conduction auditory testing. This is crucial for differentiating between conductive and sensorineural hearing impairments. The device ensures consistent and reliable stimulation, which is essential for accurate AEP measurements.
📦 Compatibility and Integration
This bone vibrator is compatible with Cadwell's Sierra II and Sierra Wave EMG/EP systems. Its integration allows for seamless operation within the existing diagnostic workflows, ensuring efficient and accurate patient assessments.
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📄 Regulatory and Compliance Information
According to the FDA's Global Unique Device Identification Database (GUDID), the Sierra II Bone Vibrator is listed under the electromyograph category, confirming its compliance with medical device regulations and standards.
Return Policy
Items are sold as-is with no returns or refunds available unless explicitly stated.
