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510(k) K241152

InSee by Tidal Medical Technologies, LLC — Product Code BWF

K241152 is an FDA 510(k) premarket notification submitted by Tidal Medical Technologies, LLC for the device "InSee". The FDA issued a decision of Substantially Equivalent on August 21, 2025. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2025
Date Received
April 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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FDA data resources