ALICE 5
FDA 510(k) clearance K040595 · decided 2004-03-18
Clearance details
- K-number
- K040595
- Device name
- ALICE 5
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-08
- Decision date
- 2004-03-18
- Days to decision
- 10 days
- Clearance type
- Abbreviated
- Product code
- OLZ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Murrysville, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electr recall (Z-1057-2008) | Respironics, Inc. | 2008-04-24 |