Model 535-03 Trace a Pace

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812755 ↗

FDA Product Code

DXH

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

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