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FDA 510(k) Application Details - K001811
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K001811
Device Name
Subsystem, Water Purification
Applicant
NEU-ION, INC.
7200 RUTHERFORD RD.
SUITE 100
BALTIMORE, MD 21244-2704 US
Other 510(k) Applications for this Company
Contact
LEE A HEIKKINEN
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
FIP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2000
Decision Date
10/25/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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