FDA device listing

Computer, Oxygen-Uptake

FDA device listing 1817941538 · Wholecare Biomedical Corporation

Key facts

Owner/operator Wholecare Biomedical Corporation
Owner/operator number 10039146
Product codes BZL
Device names BZL - Computer, Oxygen-Uptake
Device class Class II
Classification regulations (21 CFR) 868.1730
Review panels Anesthesiology
Registered establishments WHOLECARE BIOMEDICAL CORPORATION
Establishment registrations 3009507357
FEI numbers 3009507357
Establishment operations Contract Manufacturer
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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