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510(k) K200550

Vitalograph Model 2120 In2itive eDiary by Vitalograph Ireland, Ltd. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2020
Date Received
March 3, 2020
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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