RMX PHYSIOLOGICAL DATA RECORDER


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
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 02/12/2008
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