AOI CRANIAL HELMET


Device Classification Name

orthosis, cranial

510(k) Number K103362
Device Name AOI CRANIAL HELMET
Applicant
ADVANCED ORTHOPRO INC.
1820 n. illinois st.
indianapolis, 
IN 
46202

Applicant Contact mohamad mansoori
Correspondent
ADVANCED ORTHOPRO INC.
1820 n. illinois st.
indianapolis, 
IN 
46202

Correspodent Contact mohamad mansoori
Regulation Number 882.5970
Classification Product Code
MVA  
Date Received 11/17/2010
Decision Date 04/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No