Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K052227 |
Device Name |
RESPCARE FACE MASK |
Applicant |
RESPCARE INC. |
6601 LYONS ROAD, SUITES B1-B4 |
COCONUT CREEK,
FL
33073
|
|
Applicant Contact |
FRANK PELC |
Correspondent |
RESPCARE INC. |
6601 LYONS ROAD, SUITES B1-B4 |
COCONUT CREEK,
FL
33073
|
|
Correspondent Contact |
FRANK PELC |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 08/16/2005 |
Decision Date | 10/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|