CPAP SYSTEM, MODEL 102001


information about

Device Classification Name

attachment, breathing, positive end expiratory pressure

510(k) Number K001318
Device Name CPAP SYSTEM, MODEL 102001
Original Applicant
SIMS PORTEX, INC.
10 bowman dr.
keene, 
NH 
03431

Original Contact brian d farias
Regulation Number 868.5965
Classification Product Code
BYE  
Subsequent Product Code
CBI  
Date Received 04/26/2000
Decision Date 07/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No