Device Classification Name |
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
|
510(k) Number |
K910947 |
Device Name |
NEV-10 NEGATIVE PRESSURE VENTILATOR |
Applicant |
LIFECARE SERVICES, INC. |
655 ASPEN RIDGE DR. |
LAFAYETTE,
CO
80026
|
|
Applicant Contact |
HAROLD ELLERINGTON |
Correspondent |
LIFECARE SERVICES, INC. |
655 ASPEN RIDGE DR. |
LAFAYETTE,
CO
80026
|
|
Correspondent Contact |
HAROLD ELLERINGTON |
Regulation Number | 868.5935
|
Classification Product Code |
|
Date Received | 03/06/1991 |
Decision Date | 06/03/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|