FDA device listing
Reusable Adult/Pediatric Ear Clip SpO2 Sensor(1.5m),Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m),Reusable…
FDA device listing 1586871128 · Philips Medical Systems International BV
Key facts
| Proprietary names | Reusable Adult/Pediatric Ear Clip SpO2 Sensor(1.5m),Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m),Reusable Pediatric/Small/Adult Finger SpO2 Sensor |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 2939520 |
| Premarket submissions | K021300 |
| Product codes | DSI |
| Device names | DSI - Detector And Alarm, Arrhythmia |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025 |
| Review panels | Cardiovascular |
| Registered establishments | Volcano Corporation, Volcano Corporation by Volcarica S.R.L. |
| Establishment registrations | 3008363989, 3009490946 |
| FEI numbers | 3008363989, 3009490946 |
| Establishment operations | Complaint File Establishment, 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