Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082899
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K082899
Device Name
Meter, Peak Flow, Spirometry
Applicant
DYNAMITECH MEDICAL, INC
PACIFIC NORTHWEST BRANCK
611 S. SCHOOLHOUSE CREEK RD
GRANTS PASS, OR 97526 US
Other 510(k) Applications for this Company
Contact
KEITH LOWREY
Other 510(k) Applications for this Contact
Regulation Number
868.1860
More FDA Info for this Regulation Number
Classification Product Code
BZH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2008
Decision Date
03/10/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact