510(k) K242290
K242290 is an FDA 510(k) premarket notification submitted by Dormotech Medical, Ltd. for the device "DormoTech NLab". The FDA issued a decision of Substantially Equivalent on January 8, 2025. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Dormotech Medical, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2025
- Date Received
- August 2, 2024
- 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