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510(k) K021200

COMPAS by Morgan Scientific, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2002
Date Received
April 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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  • K213754 — SpiroHome Personal, SpiroHome Clinic (June 12, 2023)
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