510(k) K240271
K240271 is an FDA 510(k) premarket notification submitted by Linshom Medical, Inc. for the device "Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)". The FDA issued a decision of Substantially Equivalent on September 11, 2024. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Linshom Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2024
- Date Received
- January 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type