MPS OXIPORT AND MPS OXIPORT PLUS


Device Classification Name

device, monitoring, intracranial pressure

510(k) Number K072379
Device Name MPS OXIPORT AND MPS OXIPORT PLUS
Applicant
INNERSPACE, INC.
1622 edinger avenue, suite c
tustin, 
CA 
92780

Applicant Contact don bobo
Correspondent
INNERSPACE, INC.
1622 edinger avenue, suite c
tustin, 
CA 
92780

Correspodent Contact don bobo
Regulation Number 882.1620
Classification Product Code
GWM  
Date Received 08/24/2007
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No