510(k) K240100
K240100 is an FDA 510(k) premarket notification submitted by Snap Diagnostics, LLC for the device "SAM Model 9-10000". The FDA issued a decision of Substantially Equivalent on June 4, 2024. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Snap Diagnostics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2024
- Date Received
- January 12, 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