Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012677
Device Classification Name
Oximeter, Reprocessed
More FDA Info for this Device
510(K) Number
K012677
Device Name
Oximeter, Reprocessed
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE, MN 55369 US
Other 510(k) Applications for this Company
Contact
PATRICK FLEISCHHACKER
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
NLF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/14/2001
Decision Date
03/28/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
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