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510(k) K211387

Breathe Easy Mobile Respiratory Monitor (MRM) by Sound Life Sciences, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2021
Date Received
May 5, 2021
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

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