BCI 3403 SLEEP SCREENING PULSE OXIMETER


Device Classification Name

oximeter

510(k) Number K011156
Device Name BCI 3403 SLEEP SCREENING PULSE OXIMETER
Original Applicant
BCI, INC.
n7 w22025 johnson rd.
waukesha, 
WI 
53186

Original Contact donald alexander
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 04/16/2001
Decision Date 06/14/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No