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FDA 510(k) Application Details - K980756
Device Classification Name
Monitor, Carbon-Dioxide, Cutaneous
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510(K) Number
K980756
Device Name
Monitor, Carbon-Dioxide, Cutaneous
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD, CT 06492 US
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Contact
RICHARD CEHOVSKY
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Regulation Number
868.2480
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Classification Product Code
LKD
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More FDA Info for this Product Code
Date Received
02/27/1998
Decision Date
11/05/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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