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Ultraview DM3 Monitor

by Zoe Medical, Inc.

510(k) K093802

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K093802; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093802 Date9 Apr 2010ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-3098-2024 FDA Class II initiated 13 Aug 2024 on shared 510(k) K093802

    This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.

    • Terminated Z-2380-2012 FDA Class II initiated 6 Jun 2012 on shared 510(k) K093802

    Unit fails to power up, resulting in an equipment alarm

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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