OXISCAN II DATA MANAGEMENT SYSTEM


Device Classification Name

oximeter

510(k) Number K080348
Device Name OXISCAN II DATA MANAGEMENT SYSTEM
Applicant
AIRSEP CORP.
401 creekside dr.
buffalo, 
NY 
14228 -2085

Applicant Contact peter weiserborn
Correspondent
AIRSEP CORP.
401 creekside dr.
buffalo, 
NY 
14228 -2085

Correspodent Contact peter weiserborn
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 02/11/2008
Decision Date 10/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No