Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K051322 |
Device Name |
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS |
Applicant |
SMITHS MEDICAL INTERNATIONAL, LTD. |
N7 W22025 JOHNSON DRIVE |
WAUKESHA,
WI
|
|
Applicant Contact |
DONALD ALEXANDER |
Correspondent |
SMITHS MEDICAL INTERNATIONAL, LTD. |
N7 W22025 JOHNSON DRIVE |
WAUKESHA,
WI
|
|
Correspondent Contact |
DONALD ALEXANDER |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 05/20/2005 |
Decision Date | 08/05/2005 |
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
|
|
|