FDA 510(k), K113088, HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)

510(K) Number: K113088
Device Name: HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Manufacturer: INNERSPACE, INC
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 10/19/2011
Decision Date: 05/02/2012
Regulation Medical Specialty: Neurology

Total pages: 148
Fully redacted pages: 30
Content pages: 118