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Caredop II

by Nicolet Biomedical

510(k) K982635

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK982635 Date7 Aug 1998ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2727-2017 FDA Class II initiated 9 Jun 2017
    • Terminated Z-2726-2017 FDA Class II initiated 9 Jun 2017
    • Terminated Z-2729-2017 FDA Class II initiated 9 Jun 2017
    • Terminated Z-2728-2017 FDA Class II initiated 9 Jun 2017

    Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.

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  • Withdrawn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
JAF
Device Class
Class II
Regulation
21 CFR Part 892.1540
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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