RESUSCITATION UNIT 105


Device Classification Name

mixer, breathing gases, anesthesia inhalation

510(k) Number K103317
Device Name RESUSCITATION UNIT 105
Applicant
ATOM MEDICAL CORPORATION
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
ATOM MEDICAL CORPORATION
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5330
Classification Product Code
BZR  
Date Received 11/10/2010
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No