RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K110629
Device Name RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
Applicant
3B PRODUCTS, INC.
9109 copenhaver drive
potomac, 
MD 
20854

Applicant Contact norma f estrin, ph.d.
Correspondent
3B PRODUCTS, INC.
9109 copenhaver drive
potomac, 
MD 
20854

Correspodent Contact norma f estrin, ph.d.
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 03/04/2011
Decision Date 04/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No