Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K964719 |
Device Name |
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR |
Applicant |
HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. |
P.O. BOX 9020 |
TEMECULA,
CA
92589 -9020
|
|
Applicant Contact |
ARDEN P MORLEY |
Correspondent |
HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. |
P.O. BOX 9020 |
TEMECULA,
CA
92589 -9020
|
|
Correspondent Contact |
ARDEN P MORLEY |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 11/25/1996 |
Decision Date | 02/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|