The following data is part of a premarket notification filed by Vision Health Technology with the FDA for Dowing Ophthalmic Chair Ac-powered.
Device ID | K833539 |
510k Number | K833539 |
Device Name: | DOWING OPHTHALMIC CHAIR AC-POWERED |
Classification | Chair, Ophthalmic, Ac-powered |
Applicant | VISION HEALTH TECHNOLOGY 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HME |
CFR Regulation Number | 886.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-05 |
Decision Date | 1984-03-05 |