Nebulizer (Direct Patient Interface)
510(k) K915075
Nebulizer (Direct Patient Interface) is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Medi Nuclear Corp., Inc., cleared under FDA 510(k) K915075 on 16 Jul 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 | NumberK915075 | Date16 Jul 1992 | StatusActive |
Official records
- FDA 510(k) database K915075
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- Withdrawn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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