CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K022004
Device Name CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
Original Applicant
BIOSENSORS INTERNATIONAL-USA
20250 acacia st., suite 115
newport beach, 
CA 
92660

Original Contact jorge haider
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 06/19/2002
Decision Date 03/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No