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FDA 510(k) Application Details - K213872
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K213872
Device Name
Spirometer, Diagnostic
Applicant
Morgan Scientific, Inc.
151 Essex Street STE 8
Haverhill, MA 01832 US
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Contact
Deborah Cornish
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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
12/13/2021
Decision Date
07/15/2022
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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