FDA device listing

SH 77-1,SH 77-2,SH 77-3,SH 77-4,SH 77-5,SH 77-6,SH 77-7,SH 77-S (Set of 7 sizes)

FDA device listing 1227043821 · INSTRUMENTATION INDUSTRIES, INCORPORATED

Key facts

Proprietary names SH 77-1,SH 77-2,SH 77-3,SH 77-4,SH 77-5,SH 77-6,SH 77-7,SH 77-S (Set of 7 sizes)
Owner/operator INSTRUMENTATION INDUSTRIES, INCORPORATED
Owner/operator number 2518436
Product codes CAE
Device names CAE - Airway, Oropharyngeal, Anesthesiology
Device class Class I
Classification regulations (21 CFR) 868.5110
Review panels Anesthesiology
Registered establishments INSTRUMENTATION INDUSTRIES, INCORPORATED
Establishment registrations 2518436
FEI numbers 2518436
Establishment operations Repackager/Relabeler
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

Browse all FDA device listings