APNEACHECK


Device Classification Name

ventilatory effort recorder

510(k) Number K022294
Device Name APNEACHECK
Original Applicant
IM SYSTEMS
1055 taylor ave.
suite 300
baltimore, 
MD 
21286

Original Contact david t krausman
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 07/16/2002
Decision Date 04/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No