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FDA 510(k) Application Details - K061731
Device Classification Name
Computer, Oxygen-Uptake
More FDA Info for this Device
510(K) Number
K061731
Device Name
Computer, Oxygen-Uptake
Applicant
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL, MN 55127-8599 US
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Contact
LYNN BROSIOUS
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Regulation Number
868.1730
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Classification Product Code
BZL
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More FDA Info for this Product Code
Date Received
06/20/2006
Decision Date
09/06/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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