Ne-U07
510(k) K922923
Ne-U07 is a Class II device made by Omron Healthcare, Inc., cleared under FDA 510(k) K922923 on 15 Sep 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922923 | Date15 Sep 1992 | StatusActive |
Official records
- FDA 510(k) database K922923
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAF
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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