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510(k) K223246

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense by Baxter Healthcare Corproration — Product Code BZQ

K223246 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corproration for the device "Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense". The FDA issued a decision of Substantially Equivalent on November 18, 2022. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2022
Date Received
October 20, 2022
Clearance Type
Special
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

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FDA data resources