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510(k) K223246

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

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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