510(k) K240271

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) by Linshom Medical, Inc. — Product Code BZQ

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