FDA device listing
1077 EARTIP 12-16 BLUE,1077 EARTIP 5MM BLUE,1077 EARTIP 8-11 TRANS 50 PCS,1077 EARTIP 9-13 FOAM,EARTIP,18MM,PROBE…
FDA device listing 1713587602 · PATH
Key facts
| Proprietary names | 1077 EARTIP 12-16 BLUE,1077 EARTIP 5MM BLUE,1077 EARTIP 8-11 TRANS 50 PCS,1077 EARTIP 9-13 FOAM,EARTIP,18MM,PROBE A,EARTIP,4.5MM,PROBE S,EARTIP,4.6-7MM,PROBE A,EARTIP,6-10MM,PROBE A,Eartip, Soft Tip 10 mm,Eartip, Soft Tip 14 mm,Ear tip soft tip 9mm |
|---|---|
| Owner/operator | PATH |
| Owner/operator number | 10042983 |
| Product codes | ETT |
| Device names | ETT - Cushion, Earphone (For Audiometric Testing) |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.1100 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | PATH |
| Establishment registrations | 3008111228 |
| FEI numbers | 3008111228 |
| Establishment operations | 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