FDA device listing

Quest Peak Flow Meter

FDA device listing 1234132093 · Quest Products, Inc

Key facts

Proprietary names Quest Peak Flow Meter
Owner/operator Quest Products, Inc
Owner/operator number 9065117
Premarket submissions K101380
Product codes BZH
Device names BZH - Meter, Peak Flow, Spirometry
Device class Class II
Classification regulations (21 CFR) 868.1860
Review panels Anesthesiology
Registered establishments Quest Products, Inc
Establishment registrations 3004087544
FEI numbers 3004087544
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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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