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Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5

by Jawon Medical Co., Ltd. 510(k)

Active United States

510(k) K053556

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053556 Date31 Aug 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MNW
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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