ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK


Device Classification Name

bronchoscope (flexible or rigid)

510(k) Number K081518
Device Name ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
Applicant
PENTAX MEDICAL COMPANY
102 chestnut ridge rd.
montvale, 
NJ 
07645 -1856

Applicant Contact paul silva
Correspondent
PENTAX MEDICAL COMPANY
102 chestnut ridge rd.
montvale, 
NJ 
07645 -1856

Correspodent Contact paul silva
Regulation Number 874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received 05/30/2008
Decision Date 09/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No