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510(k) K222823

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2023
Date Received
September 19, 2022
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.

  • K183349 — AeroDVx System (July 19, 2019)
  • 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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