Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K955507
Device Classification Name
Ventilator, Emergency, Manual (Resuscitator)
More FDA Info for this Device
510(K) Number
K955507
Device Name
Ventilator, Emergency, Manual (Resuscitator)
Applicant
GRAYCO, INC.
1212 7TH ST.
CLARKSTON, WA 99403 US
Other 510(k) Applications for this Company
Contact
THOMAS C GRAY
Other 510(k) Applications for this Contact
Regulation Number
868.5915
More FDA Info for this Regulation Number
Classification Product Code
BTM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/1995
Decision Date
08/15/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact