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FDA 510(k) Application Details - K211387
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K211387
Device Name
Monitor, Breathing Frequency
Applicant
Sound Life Sciences, Inc.
Startup Hall, Box 354625, 1100 NE Campus Parkway, Suite 200
Seattle, WA 98195-4625 US
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Contact
Kamal Shah
Other 510(k) Applications for this Contact
Regulation Number
868.2375
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Classification Product Code
BZQ
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More FDA Info for this Product Code
Date Received
05/05/2021
Decision Date
11/23/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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