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510(k) K240293

STS by Techbopulm, Ltd. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2024
Date Received
February 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

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