CASSIE
510(k)K252628AnesthesiologyMNR
Wesper, Inc. is listed for CASSIE (K252628). The FDA list gives April 27, 2026 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MNR. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252628
- Date of final decision
- April 27, 2026
- Company on the FDA list
- Wesper, Inc.
- Lead panel
- Anesthesiology
- Primary product code
- MNR
- openFDA device name for the code
- Ventilatory Effort Recorder
- Device class
- 2
- Regulation number
- 868.2375
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary