Dgh Model 9000
510(k) K965127
Dgh Model 9000 is a Class II device made by Dgh Technology Inc., cleared under FDA 510(k) K965127 on 17 Mar 1997, 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 | NumberK965127 | Date17 Mar 1997 | StatusActive |
Official records
- FDA 510(k) database K965127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HQC
- FDA applicant
- Dgh Technology, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 886.4670
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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