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FDA 510(k) Application Details - K003943
Device Classification Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
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510(K) Number
K003943
Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Applicant
LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL 4051 CH
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Contact
JEAN-PIERRE PALMA
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Regulation Number
868.2500
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Classification Product Code
KLK
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Date Received
12/21/2000
Decision Date
05/04/2001
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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