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Model 2120IS Series Maternal/Fetal Monitor

by GE Medical Systems Information Technologies

510(k) K021135

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 NumberK021135 Date9 May 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1291-03 FDA Unclassified (pre-2012) initiated 21 May 2003

    The 2120 Main Board on device lacks required external safety 'watchdog' circuit.

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  • Withdrawn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
HGM
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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