FLEXISCOPE IQ 101


Device Classification Name

endoscopic video imaging system/component, gastroenterology-urology

510(k) Number K992362
Device Name FLEXISCOPE IQ 101
Applicant
SCHOELLY FIBEROPTIC, GMBH
45 pontiac rd.
newton, 
MA 
02248

Applicant Contact joseph ress
Correspondent
SCHOELLY FIBEROPTIC, GMBH
45 pontiac rd.
newton, 
MA 
02248

Correspodent Contact joseph ress
Regulation Number 876.1500
Classification Product Code
FET  
Date Received 07/15/1999
Decision Date 08/05/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No