Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K153563 |
Device Name |
AirFit F20 |
Applicant |
RESMED LTD. |
1 ELIZABETH MACARTHUR DRIVE |
BELLA VISTA,
AU
2153
|
|
Applicant Contact |
Johanna Wright |
Correspondent |
RESMED CORP. |
9001 SPECTRUM CENTER BOULEVARD |
San Diego,
CA
92123
|
|
Correspondent Contact |
Larissa D'Andrea |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 12/14/2015 |
Decision Date | 05/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|