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FDA 510(k) Application Details - K973545
Device Classification Name
Analyzer, Gas, Oxygen, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K973545
Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant
VACUMED, DIV. OF VACUMETRICS, INC.
2225 EAST MURRAY HOLLADAY RD.
SUITE 207
SALT LAKE CITY, UT 84117 US
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Contact
RAE NADINE SMITH
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Regulation Number
868.1720
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Classification Product Code
CCL
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More FDA Info for this Product Code
Date Received
09/18/1997
Decision Date
05/26/1998
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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