VIEWPOINT ENT/ORTHOPEDIC OPTION


Device Classification Name

neurological stereotaxic instrument

510(k) Number K991256
Device Name VIEWPOINT ENT/ORTHOPEDIC OPTION
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland, 
OH 
44143

Applicant Contact elaine k keeler
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland, 
OH 
44143

Correspodent Contact elaine k keeler
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 04/13/1999
Decision Date 10/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No