Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K051262 |
Device Name |
ESPRIT VENTILATOR NEONATAL 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 | 05/16/2005 |
Decision Date | 07/08/2005 |
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
|
|
|