FDA 510(k), K061640, INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
FDA 510(k), K061640, INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
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510(K) Number: K061640
Device Name: INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
Manufacturer: INTEGRA LIFESCIENCES CORPORATION
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 06/12/2006
Decision Date: 07/27/2006
Regulation Medical Specialty: Neurology
Device Name: INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
Manufacturer: INTEGRA LIFESCIENCES CORPORATION
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 06/12/2006
Decision Date: 07/27/2006
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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