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FDA 510(k) Application Details - K092950
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K092950
Device Name
Oximeter
Applicant
SOLARIS MEDICAL TECHNOLOGY, INC.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
DQA
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More FDA Info for this Product Code
Date Received
09/24/2009
Decision Date
03/12/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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