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FDA 510(k), K080217, COMPONENT NEUROMONITORING SYSTEM
FDA 510(k), K080217, COMPONENT NEUROMONITORING SYSTEM
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510(K) Number: K080217
Device Name: COMPONENT NEUROMONITORING SYSTEM
Manufacturer: MOBERG RESEARCH, INC.
Device Classification Name: amplitude-integrated electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 01/29/2008
Decision Date: 11/05/2008
Regulation Medical Specialty: Neurology
Device Name: COMPONENT NEUROMONITORING SYSTEM
Manufacturer: MOBERG RESEARCH, INC.
Device Classification Name: amplitude-integrated electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 01/29/2008
Decision Date: 11/05/2008
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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