510(k) K941723
- Device
- WELCH ALLYN GLAUCOMA DETECTOR
- Applicant
- WELCH ALLYN, INC.
- 510(k) number
- K941723
- Product code
- HOO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-06-06
- Date received
- 1994-04-07
- Regulation
- 886.1605
- Classification name
- Perimeter, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT P GUCCIARDI
- Address
- 4341 State St. Rd. P.O. Box 220 Skaneateles Falls NY US 13153 13153
FDA Registration Numbers#
- 9611269
- 3033566
- 2918630
- 3013436538
- 3020723591
- 3016965632
- 1836161
- 3041277555
- 3013403214
- 3010774780
- 9710516
- 3017591190
Source Documents#
Other 510(k) Records For Product Code HOO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K832800 | AUTOMATIC TANGENT SCREEN 50 | CooperVision, Inc. | 1983-09-29 |
Legacy Summary#
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FDA Review#
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