SWIFT FX BELLA


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K112489
Device Name SWIFT FX BELLA
Applicant
RESMED LTD.
1 elizabeth macarthur dr
bella vista newsouth wales, 

AU

2153

Applicant Contact kim k lee
Correspondent
RESMED LTD.
1 elizabeth macarthur dr
bella vista newsouth wales, 

AU

2153

Correspodent Contact kim k lee
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 08/29/2011
Decision Date 12/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No