Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K062019 |
Device Name |
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD |
Applicant |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
6601 LYONS ROAD |
SUITES B1-B4 |
COCONUT CREEK,
FL
33073
|
|
Applicant Contact |
FRANK PELC |
Correspondent |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
6601 LYONS ROAD |
SUITES B1-B4 |
COCONUT CREEK,
FL
33073
|
|
Correspondent Contact |
FRANK PELC |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 07/17/2006 |
Decision Date | 08/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|