Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K041412 |
Device Name |
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 |
Applicant |
RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. |
CARLSBAD,
CA
92009
|
|
Applicant Contact |
MARY FUNK |
Correspondent |
RESPIRONICS CALIFORNIA, INC. |
2271 COSMOS CT. |
CARLSBAD,
CA
92009
|
|
Correspondent Contact |
MARY FUNK |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 05/27/2004 |
Decision Date | 06/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|