Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K001208 |
Device Name |
ESPIRT |
Applicant |
RESPIRONICS, INC. |
1501 ARDMORE BLVD. |
PITTSBURGH,
PA
15221 -4401
|
|
Applicant Contact |
KATHY MOORE |
Correspondent |
RESPIRONICS, INC. |
1501 ARDMORE BLVD. |
PITTSBURGH,
PA
15221 -4401
|
|
Correspondent Contact |
KATHY MOORE |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/14/2000 |
Decision Date | 05/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|