FDA device listing

Monitor, Bed Patient

FDA device listing 1956560664 · STRYKER CORP.

Key facts

Owner/operator STRYKER CORP.
Owner/operator number 1811755
Product codes KMI
Device names KMI - Monitor, Bed Patient
Device class Class I
Classification regulations (21 CFR) 880.2400
Review panels General Hospital
Registered establishments STRYKER MEDICAL, Stryker Sustainability Solutions, Stryker Tijuana Operations
Establishment registrations 1831750, 3009350690, 3020163307
FEI numbers 1831750, 3009350690, 3020163307
Establishment operations Complaint File Establishment, Manufacturer, Reprocessor of Single Use Devices, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

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

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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