Airprep System - Model 9001
510(k) K974488
Airprep System - Model 9001 is a medical device (FDA Class II; FDA product code KOJ, Airbrush) made by Asi Medical, Inc., cleared under FDA 510(k) K974488 on 26 May 1998, 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 | NumberK974488 | Date26 May 1998 | StatusActive |
Official records
- FDA 510(k) database K974488
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KOJ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6080
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code KOJ (Airbrush).
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