BREEZE SLEEPGEAR WITH DREAMSEAL


information about

Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K002001
Device Name BREEZE SLEEPGEAR WITH DREAMSEAL
Original Applicant
PURITAN BENNETT CORP.
2800 northwest blvd.
minneapolis, 
MN 
55441

Original Contact darin busch
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 06/30/2000
Decision Date 09/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No