SANSIBAR CPAP SYSTEM


information about

Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K000888
Device Name SANSIBAR CPAP SYSTEM
Original Applicant
PRYM MEDICAL LTD.
117 ahuzah st.
ra’ananna, 

IL

43373

Original Contact shoshana friedman
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 03/20/2000
Decision Date 08/15/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No