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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K080375
Device Name RMX PHYSIOLOGICAL DATA RECORDER
Applicant
S.L.P. LTD.
62 ANILEVITCH ST.
TEL-AVIV,  IL 67060
Applicant Contact NOAM HADAS
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact J.A. VAN VUGT
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/12/2008
Decision Date 09/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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