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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, continuous, facility use
510(k) Number K213098
Device Name Panther 5
Origin Medical Devices
23 Corporate Plaza
Newport Beach,  CA  92660
Applicant Contact Brent Chamblee
Arazy Group Consultants Inc.
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number868.5895
Classification Product Code
Date Received09/24/2021
Decision Date 07/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No