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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K193068
Device Name AIROS 8 Sequential Compression Device
Applicant
Airos Medical, Inc.
2501 Monroe Blvd. Suite 1200
Audubon,  PA  19403
Applicant Contact Darren Behuniak
Correspondent
Airos Medical, Inc.
2501 Monroe Blvd. Suite 1200
Audubon,  PA  19403
Correspondent Contact Darren Behuniak
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/04/2019
Decision Date 12/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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