The following data is part of a premarket notification filed by Oridion Ltd. with the FDA for Polaris 2004 Capnograph.
| Device ID | K040011 |
| 510k Number | K040011 |
| Device Name: | POLARIS 2004 CAPNOGRAPH |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION LTD. 21 HIGHLAND CIRCLE Needham, MA 02494 -3038 |
| Contact | Dominic Corsale |
| Correspondent | Dominic Corsale ORIDION LTD. 21 HIGHLAND CIRCLE Needham, MA 02494 -3038 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-05 |
| Decision Date | 2004-05-13 |
| Summary: | summary |