NE-U04/NE U04F
FDA 510(k) clearance K923024 · decided 1992-09-15
Clearance details
- K-number
- K923024
- Device name
- NE-U04/NE U04F
- Applicant
- Omron Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-23
- Decision date
- 1992-09-15
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE- recall (Z-0382-05) | Omron Healthcare, Inc. | 2005-01-05 |