BREATH SHAKE


Device Classification Name

percussor, powered-electric

510(k) Number K121587
Device Name BREATH SHAKE
Applicant
CHEEN HOUNG ENT. CO. LTD.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
CHEEN HOUNG ENT. CO. LTD.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5665
Classification Product Code
BYI  
Date Received 05/31/2012
Decision Date 11/22/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No