Product code

JEZ: Monitor, lung water measurement

FDA product code · Class III · Anesthesiology

Key facts

Product code JEZ
Device Monitor, lung water measurement
Device class Class III
Regulation number 868.2450
Review panel Anesthesiology
Medical specialty Anesthesiology
Submission type PMA
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • 1–9 PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • None MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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