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510(k) K212938

Vitalograph Model 6000 Alpha by Vitalograph Ireland, Ltd. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2022
Date Received
September 15, 2021
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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