FDA device listing

Bajio Rx Frames

FDA device listing 1964443039 · Bajio, Inc.

Key facts

Proprietary names Bajio Rx Frames
Owner/operator Bajio, Inc.
Owner/operator number 10078729
Product codes HQZ
Device names HQZ - Frame, Spectacle
Device class Class I
Classification regulations (21 CFR) 886.5842
Review panels Ophthalmic
Registered establishments BAJIO, INC.
Establishment registrations 3017358759
FEI numbers 3017358759
Establishment operations 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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