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FDA 510(k) Application Details - K001866
Device Classification Name
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
More FDA Info for this Device
510(K) Number
K001866
Device Name
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Applicant
RADIOMETER MEDICAL A/S
AKANDEVEJ 21
DK-2700 BRONSHOJ DK-2700 DK
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Contact
KRISTEN RONO
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Regulation Number
868.2500
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Classification Product Code
LPP
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Date Received
06/20/2000
Decision Date
12/07/2000
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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