SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER


codes

Device Classification Name

oximeter

510(k) Number K001995
Device Name SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
Original Applicant
QRS DIAGNOSTIC, LLC.
14755 27th ave.north
plymouth, 
MN 
55447

Original Contact jill r krall
Regulation Number 870.2700
Classification Product Code
DQA  
Subsequent Product Code
BZQ  
Date Received 06/30/2000
Decision Date 09/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No