Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961598
Device Classification Name
Detector, Bubble, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K961598
Device Name
Detector, Bubble, Cardiopulmonary Bypass
Applicant
ROCKY MOUNTAIN RESEARCH, INC.
2715 EAST 3300 SOUTH
SALT LAKE CITY, UT 84109 US
Other 510(k) Applications for this Company
Contact
ROBERT W GRIFFITHS
Other 510(k) Applications for this Contact
Regulation Number
870.4205
More FDA Info for this Regulation Number
Classification Product Code
KRL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/1996
Decision Date
10/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact