The following data is part of a premarket notification filed by Oridion Capnography, Inc. with the FDA for Capnostream 20p With Masimo Spo2 Board.
| Device ID | K101995 |
| 510k Number | K101995 |
| Device Name: | CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD |
| Classification | Oximeter |
| Applicant | ORIDION CAPNOGRAPHY, INC. 160 GOULD STREET Needham Heights, MA 02494 |
| Contact | Rachel Weissbrod |
| Correspondent | Rachel Weissbrod ORIDION CAPNOGRAPHY, INC. 160 GOULD STREET Needham Heights, MA 02494 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-14 |
| Decision Date | 2011-01-11 |
| Summary: | summary |