FDA device listing
989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,989803177951 Microstream® EtCO2 Consumables Smart…
FDA device listing 1545852130 · Philips Medical Systems International BV
Key facts
| Proprietary names | 989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,989803177951 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult,989803177961 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Adult Long,989803177971 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Pediatric,989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long,989803182951 Microstream®… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K011536 |
| Product codes | CCK |
| Device names | CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400 |
| Review panels | Anesthesiology |
| Registered establishments | Philips Electronics Ltd, Philips North America LLC |
| Establishment registrations | 3000126629, 3016618143 |
| FEI numbers | 3000126629, 3016618143 |
| Establishment operations | Complaint File Establishment, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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