510(k) K893968
- Device
- Vkg 2000 Video Keratometer
- Applicant
- TECHNITEX, INC.
- 510(k) number
- K893968
- Product code
- HJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-09-11
- Date received
- 1989-06-02
- Regulation
- 886.1350
- Classification name
- Photokeratoscope
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD SPAIN
- Address
- 11211 Richmond Ave., Suite 103 Houston TX US 77082 77082
FDA Registration Numbers#
- 2918630
- 3009337401
- 1836161
- 3013403214
- 9611516
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901523 | VKG 1000, VIDEO KERATOGRAPH | The Sanborn Co. | 1990-06-27 |
| K842128 | AMERICAN MEDICAL OPTICS PHOTOKERATO | American Medical Optics | 1984-08-07 |
| K830290 | DORC CONTACT/PHOTO DERATOSCOPE | Jedmed Instrument Co. | 1983-03-09 |
| K781650 | TERRY KERATOMETER | Clifford M. Terry, M.C. | 1978-10-17 |