510(k) K244027
K244027 is an FDA 510(k) premarket notification submitted by Huxley Medical for the device "SANSA HSAT". The FDA issued a decision of Substantially Equivalent on January 28, 2025. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Huxley Medical has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2025
- Date Received
- December 30, 2024
- Clearance Type
- Special
- 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