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510(k) K252628

CASSIE by Wesper, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2026
Date Received
August 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Wesper, Inc.

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  • K203343 — Wesper Lab (December 21, 2021)

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