FDA device listing
Xinakng, Nellcor 9pin Oximax Disposable Adult L type Non-woven Spo2 Sensor, model: XDBN,Xinakng, Nellcor 9pin Oximax…
FDA device listing 1198188414 · Xinkang Medical Instrument Co. Ltd.
Key facts
| Proprietary names | Xinakng, Nellcor 9pin Oximax Disposable Adult L type Non-woven Spo2 Sensor, model: XDBN,Xinakng, Nellcor 9pin Oximax Disposable Adult Non-woven Spo2 Sensor, model: XDAN,Xinakng, Nellcor 9pin Oximax Disposable Pediatric Non-woven Spo2 Sensor, model: XDPN,Xinkang, BCI 9Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF1,Xinkang, BCI 9Pin Reusable Adult Silicone Soft Spo2 Sensor, model… |
|---|---|
| Owner/operator | Xinkang Medical Instrument Co. Ltd. |
| Owner/operator number | 10078983 |
| Premarket submissions | K201360 |
| Product codes | DQA |
| Device names | DQA - Oximeter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2700 |
| Review panels | Cardiovascular |
| Registered establishments | XINKANG MEDICAL INSTRUMENT CO. LTD. |
| Establishment registrations | 3017953522 |
| FEI numbers | 3017953522 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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