ACCESS ALERT GAUGE


definition

Device Classification Name

accessories, blood circuit, hemodialysis

510(k) Number K002372
Device Name ACCESS ALERT GAUGE
Original Applicant
MEDISYSTEMS CORP.
1201 3rd ave.
seattle, 
WA 
98101 -3016

Original Contact fredric swindler
Regulation Number 876.5820
Classification Product Code
KOC  
Date Received 08/04/2000
Decision Date 10/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No