Component Neuromonitoring System
FDA 510(k) K080217 · Moberg Research, Inc.
510(k) numberK080217
Submission
- Device name
- Component Neuromonitoring System
- Applicant
- Moberg Research, Inc.
Ambler, PA, US - Received
- January 29, 2008
- Decision date
- November 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- OMA – Amplitude-Integrated Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
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More from Natus Medical, Inc.
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|---|---|---|
| K192572 | CNS EnvisionOLT · Traditional | 12/17/2019SE |
Questions and answers
When was Component Neuromonitoring System cleared by the FDA?
Component Neuromonitoring System (K080217) received a 510(k) decision of Substantially Equivalent on November 5, 2008, 281 days after the submission was received.
What is the product code of K080217?
The FDA product code is OMA – Amplitude-Integrated Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.