SLEEPSCREEN/APNOESCREEN CARDIO


Device Classification Name

ventilatory effort recorder

510(k) Number K021138
Device Name SLEEPSCREEN/APNOESCREEN CARDIO
Original Applicant
ERICH JAEGER GMBH
22705 savi ranch pkwy.
yorba linda, 
CA 
92887 -4645

Original Contact brian long
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 04/09/2002
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No