MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
FDA 510(k) clearance K022677 · decided 2002-09-11
Clearance details
- K-number
- K022677
- Device name
- MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
- Applicant
- Alaris Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-12
- Decision date
- 2002-09-11
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built recall (Z-1711-2008) | Cardinal Health 303 Inc DBA Alaris Products | 2008-06-10 |
| U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System recall (Z-1712-2008) | Cardinal Health 303 Inc DBA Alaris Products | 2008-06-10 |