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Lifedop Doppler

by Summit Doppler Systems, Inc.

510(k) K024197

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 NumberK024197 Date3 Jan 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1131-2018 FDA Class II initiated 6 Oct 2017

    The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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  • Withdrawn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
KNG
Device Class
Class II
Regulation
21 CFR Part 884.2660
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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