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510(k) K183349

AeroDVx System by Sun Scientific, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2019
Date Received
December 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Sun Scientific, Inc.

  • K222823 — AeroDVx Arm System (September 7, 2023)
  • K070457 — SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB (May 16, 2007)

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  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
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