Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K123957 |
Device Name |
PNEUPAC PARAPAC PLUS |
Applicant |
SMITHS MEDICAL INTERNATIONAL LTD. |
BRAMINGHAM BUSINESS PARK |
ENTERPRISE WAY |
LUTON, BEDFORDSHIRE,
GB
LU3 4BU
|
|
Applicant Contact |
LORI BERENDS |
Correspondent |
SMITHS MEDICAL INTERNATIONAL LTD. |
BRAMINGHAM BUSINESS PARK |
ENTERPRISE WAY |
LUTON, BEDFORDSHIRE,
GB
LU3 4BU
|
|
Correspondent Contact |
LORI BERENDS |
Regulation Number | 868.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2012 |
Decision Date | 09/16/2013 |
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
|
|
|