510(k) K834145
- Device
- ERGO DIAGNOSTIC CARD
- Applicant
- AMERICAN ERGO SYSTEMS
- 510(k) number
- K834145
- Product code
- HOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-16
- Date received
- 1983-12-01
- Regulation
- 886.1150
- Classification name
- Chart, Visual Acuity
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 2518410
- 3007576405
- 3019924
- 3013534308
- 3008248594
- 1054713
- 2085143
- 3042228518
- 3005785090
- 9710098
- 1041845
- 3014273520
- 3011080538
- 1820463
- 3015392301
- 3009578732
- 3008044461
- 3010227033
- 3004784203
- 3006654680
- 9680874
- 3005273623
- 9613910
- 3007913988
- 3033566
- 1530895
- 1000533313
- 3038356864
- 3010774780
- 8030392
- 3009173773
- 3005771344
- 3018501318
- 1836161
- 3009275598
- 3003951061
- 9615030
- 3013682704
- 2936921
- 3008058416
- 3026222938
- 1319721
- 3013148497
- 3004167900
- 3004765453
- 3024088964
- 3015972897
- 3010147274
- 2521877
- 3008058195
- 9611269
- 3013003882
- 9616199
- 3020410096
- 2435946
- 1527853
- 3003851947
- 3005755367
- 3004095901
- 2952604
- 3009410372
- 3031081959
- 3011659880
- 1419226
- 8043965
- 3011422483
- 3013846070
- 3004593486
- 3013576617
- 3009132348
- 3008044477
- 1418300
- 3020246591
- 3010610157
- 3013436538
- 9617474
- 3012448035
- 2031962
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100095 | CENTRAL VISION ANALYZER MODEL 1000 | Vimetrics,Llc. | 2010-05-10 |
| K944156 | HEINE LAMBDA 100 | Heine USA , Ltd. | 1995-01-12 |
| K881971 | OCCU-TECH VISION TEST | Applied Vision Concepts, Inc. | 1988-11-25 |
| K883337 | PL 20/20 INFANT VISION TESTER | Optimed Technologies, Inc. | 1988-10-31 |
| K882634 | VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE | Vistech Consultants, Inc. | 1988-07-15 |
| K881358 | PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM | Neuroscientific Corp. | 1988-06-27 |
| K881059 | MCT 8000 (MULTI-VISION CONTRAST TESTER) | Vistech Consultants, Inc. | 1988-04-04 |
| K881023 | VCTS 6500 SYSTEM | Vistech Consultants, Inc. | 1988-04-01 |
| K881022 | VCTS MARKETING PROGRAM SYSTEM | Vistech Consultants, Inc. | 1988-04-01 |
| K881021 | VCTS 700S SYSTEM | Vistech Consultants, Inc. | 1988-04-01 |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Fred Sammons, Inc. | 1988-04-01 |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | Stereo Optical Co., Inc. | 1988-03-17 |
| K875112 | MENTOR B-VAT(TM) II VIDEO TESTER | Mentor O & O, Inc. | 1988-03-08 |
| K873916 | 'E' CUBE AND 'E' PAD | Richmond Products, Inc. | 1987-12-11 |
| K873909 | READING CHARTS-CARDS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | 1987-10-28 |
Legacy Summary#
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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