HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM


Device Classification Name

ventilatory effort recorder

510(k) Number K073269
Device Name HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
Applicant
HYPNOCORE, LTD.
291 hillside avenue
somerset, 
MA 
02726

Applicant Contact george j hattub
Correspondent
HYPNOCORE, LTD.
291 hillside avenue
somerset, 
MA 
02726

Correspodent Contact george j hattub
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 11/21/2007
Decision Date 04/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No