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Mac 800 Resting ECG Analysis System

by Ge Medical Syst. Information Technologies

510(k) K090212

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 · Special NumberK090212 Date19 Feb 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0645-2010 FDA Unclassified (pre-2012) initiated 10 Dec 2009

    GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.

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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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