FDA device listing

Philips M3001A Multi Measurement Server

FDA device listing 1659574509 · Philips Medical Systems International BV

Key facts

Proprietary names Philips M3001A Multi Measurement Server
Owner/operator Philips Medical Systems International BV
Owner/operator number 1217116
Premarket submissions K090360
Product codes DPZ, DQA
Device names DPZ - Oximeter, Ear, DQA - Oximeter
Device class Class II
Classification regulations (21 CFR) 870.2700, 870.2710
Review panels Cardiovascular
Registered establishments Philips Electronics Ltd, Philips Medizin Systeme Boeblingen GmbH
Establishment registrations 9610816, 3000126629
FEI numbers 3000126629, 3002807167
Establishment operations Complaint File Establishment, Manufacturer, Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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