The following data is part of a premarket notification filed by Stereo Optical Co., Inc. with the FDA for Optec 2300 Afvt, Armed Forces Vision Tester.
Device ID | K904828 |
510k Number | K904828 |
Device Name: | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER |
Classification | Refractometer, Ophthalmic |
Applicant | STEREO OPTICAL CO., INC. 3539 NORTH KENTON Chicago, IL 60641 |
Contact | Joseph Andera |
Correspondent | Joseph Andera STEREO OPTICAL CO., INC. 3539 NORTH KENTON Chicago, IL 60641 |
Product Code | HKO |
CFR Regulation Number | 886.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-24 |
Decision Date | 1991-01-18 |