Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K944347 |
Device Name |
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR) |
Applicant |
PURITAN BENNETT CORP. |
10800 PFLUMM RD. |
LENEXA,
KS
66215
|
|
Applicant Contact |
C. MARSHALL SMITH |
Correspondent |
PURITAN BENNETT CORP. |
10800 PFLUMM RD. |
LENEXA,
KS
66215
|
|
Correspondent Contact |
C. MARSHALL SMITH |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 09/06/1994 |
Decision Date | 12/12/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|