Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K030797 |
Device Name |
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM |
Applicant |
RESMED CORP. |
14040 DANIELSON ST. |
POWAY,
CA
92064 -6857
|
|
Applicant Contact |
DAVID D'CRUZ |
Correspondent |
RESMED CORP. |
14040 DANIELSON ST. |
POWAY,
CA
92064 -6857
|
|
Correspondent Contact |
DAVID D'CRUZ |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/13/2003 |
Decision Date | 03/10/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|