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Modification to Encompass

by Heartlab, Inc.

510(k) K040896

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK040896 Date16 Jul 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0543-2009 FDA Unclassified (pre-2012) initiated 23 Jul 2008

    If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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