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510(k) K180173

Freespira by Palo Alto Health Sciences, Inc. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2018
Date Received
January 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Palo Alto Health Sciences, Inc.

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