MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
FDA 510(k) clearance K041241 · decided 2004-07-06
Clearance details
- K-number
- K041241
- Device name
- MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
- Applicant
- Alaris Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-11
- Decision date
- 2004-07-06
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Alaris" System with Guardrails" Suite MX with Point of Care Unit recall (Z-1645-2026) | CareFusion 303, Inc. | 2026-03-26 |
| Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode s recall (Z-0534-2014) | CareFusion 303, Inc. | 2013-12-20 |