SIGMA DELTA


information about

Device Classification Name

vaporizer, anesthesia, non-heated

510(k) Number K002343
Device Name SIGMA DELTA
Original Applicant
PENLON LTD.
radley road
aingdon
oxonn, 

GB

ox14 3ph

Original Contact anthony parsons
Regulation Number 868.5880
Classification Product Code
CAD  
Date Received 08/01/2000
Decision Date 06/08/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls