Oridion Capnography, Inc.
Jerusalem, IL
Oridion Capnography, Inc. appears in FDA device records in Jerusalem, IL. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Oridion Capnography, Inc. between 2006 and 2011. The busiest year on record is 2006, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101995 | CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD | DQA | Substantially Equivalent | |
| K094012 | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE | CCK | Substantially Equivalent | |
| K082268 | CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX | DQA | Substantially Equivalent | |
| K072295 | CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE | DQA | Substantially Equivalent | |
| K060065 | CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR | DQA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0178-2008 | Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical | Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall. | Terminated | ||
| Z-0177-2008 | Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical | Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain