Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K921982 |
Device Name |
MATRX HOPE(R) 5 RESUSCITATOR |
Applicant |
MATRIX MEDICA, INC. |
145 MID COUNTY DR. |
ORCHARD PARK,
NY
|
|
Applicant Contact |
MICHAEL SWART |
Correspondent |
MATRIX MEDICA, INC. |
145 MID COUNTY DR. |
ORCHARD PARK,
NY
|
|
Correspondent Contact |
MICHAEL SWART |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 04/28/1992 |
Decision Date | 10/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|