Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K933947 |
Device Name |
LIFECARE CPAP-200 |
Applicant |
LIFECARE INTERNATIONAL,INC. |
655 ASPEN RIDGE DR. |
LAFAYETTE,
CO
80026 -9341
|
|
Applicant Contact |
HAROLD ELLERINGTON |
Correspondent |
LIFECARE INTERNATIONAL,INC. |
655 ASPEN RIDGE DR. |
LAFAYETTE,
CO
80026 -9341
|
|
Correspondent Contact |
HAROLD ELLERINGTON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 08/12/1993 |
Decision Date | 11/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|