IEC MEDSIGHT AND MEDBRIGHT


Device Classification Name

endoscopic video imaging system/component, gastroenterology-urology

510(k) Number K080809
Device Name IEC MEDSIGHT AND MEDBRIGHT
Applicant
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
731-733 shotgun rd.
ft. lauderdale, 
FL 
33326

Applicant Contact gerald goifitzer
Correspondent
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
731-733 shotgun rd.
ft. lauderdale, 
FL 
33326

Correspodent Contact gerald goifitzer
Regulation Number 876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received 03/21/2008
Decision Date 08/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No