510(k) K832800
- Device
- AUTOMATIC TANGENT SCREEN 50
- Applicant
- COOPERVISION, INC.
- 510(k) number
- K832800
- Product code
- HOO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-29
- Date received
- 1983-08-18
- Regulation
- 886.1605
- Classification name
- Perimeter, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- Permalens House 1 Botley Rd., Hedge End Southampton GB S033HB S033HB
FDA Registration Numbers#
- 9611269
- 3020723591
- 9710516
- 2918630
- 1836161
- 3033566
- 3013436538
- 3010774780
- 3013403214
- 3041277555
- 3016965632
- 3017591190
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941723 | WELCH ALLYN GLAUCOMA DETECTOR | Welch Allyn, Inc. | 1994-06-06 |
| K930448 | MARCO PROJECTION PERIMETER | Marco Ophthalmic, Inc. | 1993-06-21 |
| K873912 | RICHMOND VISUAL FIELD SCREENER | Richmond Products, Inc. | 1987-11-02 |
| K864467 | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN | Keeler Instruments, Inc. | 1986-12-15 |
| K860115 | DIGILAB CAMBRIDGE PERIMETER | Bio-Rad | 1986-02-27 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases