CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
FDA 510(k) clearance K060065 · decided 2006-05-04
Clearance details
- K-number
- K060065
- Device name
- CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
- Applicant
- Oridion Capnography, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-09
- Decision date
- 2006-05-04
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Jerusalem, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Oridion Capnography
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. recall (Z-2232-2009) | Oridion Medical 1987 Ltd. | 2009-09-21 |
| Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion M recall (Z-0177-2008) | Oridion Capnography Inc | 2007-11-28 |
| Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion recall (Z-0178-2008) | Oridion Capnography Inc | 2007-11-28 |