SK MED M201 MIXER


Device Classification Name

mixer, breathing gases, anesthesia inhalation

510(k) Number K022864
Device Name SK MED M201 MIXER
Original Applicant
SK MED
16000 sherman way #224
van nuys, 
CA 
91406

Original Contact dipak ghosh
Regulation Number 868.5330
Classification Product Code
BZR  
Subsequent Product Code
CCL  
Date Received 08/28/2002
Decision Date 04/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No