SLEEP PAT 200 DEVICE


Device Classification Name

ventilatory effort recorder

510(k) Number K010156
Device Name SLEEP PAT 200 DEVICE
Original Applicant
ITAMAR MEDICAL (C.M.) 1997 LTD.
377 route 17
hasbrouck heights, 
NJ 
07604

Original Contact george h myers
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 01/16/2001
Decision Date 06/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No