FDA device listing
103520 Non-Adhesive Wrap,AC-150 Adapter Cable,AC-250 Adapter Cable,AC-750 Adapter Cable,EC-MI Ear Clip,GAS-0812 Service…
FDA device listing 1738851328 · SENTEC AG
Key facts
| Proprietary names | 103520 Non-Adhesive Wrap,AC-150 Adapter Cable,AC-250 Adapter Cable,AC-750 Adapter Cable,EC-MI Ear Clip,GAS-0812 Service Gas,GEL-04 Contact Gel,GEL-SD Single Dose Contact Gel,MARe-MI Multi-Site Attachment Ring Easy,MARe-SF Multi-Site Attachment Ring Easy,MAR-MI Multi-site Attachment Ring,MAR-SF Multi-site Attachment Ring,MC-I Membrane Changer Insert,MC Membrane Changer,MR Membrane Changer,OV-A/P/N… |
|---|---|
| Owner/operator | SENTEC AG |
| Owner/operator number | 9064082 |
| Premarket submissions | K151329 |
| Product codes | DPZ, KLK, LKD, LPP |
| Device names | DPZ - Oximeter, Ear, KLK - Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, LKD - Monitor, Carbon-Dioxide, Cutaneous, LPP - Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.2480, 868.2500, 870.2710 |
| Review panels | Anesthesiology, Cardiovascular |
| Registered establishments | SENTEC AG |
| Establishment registrations | 3004149774 |
| FEI numbers | 3004149774 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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