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FDA 510(k) Application Details - K150137
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K150137
Device Name
Spirometer, Diagnostic
Applicant
Cohero Health LLC
335 Madison Avenue, 3rd Floor
New York, NY 10017 US
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Contact
Melissa Manice
Other 510(k) Applications for this Contact
Regulation Number
868.1840
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Classification Product Code
BZG
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More FDA Info for this Product Code
Date Received
01/22/2015
Decision Date
05/27/2015
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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