The following data is part of a premarket notification filed by Techna Vision with the FDA for Techna Vision, Inc. Electric Chair.
Device ID | K853743 |
510k Number | K853743 |
Device Name: | TECHNA VISION, INC. ELECTRIC CHAIR |
Classification | Chair, Ophthalmic, Ac-powered |
Applicant | TECHNA VISION 11489 WOODSIDE AVE. Santee, CA 92071 |
Contact | James T Kelley |
Correspondent | James T Kelley TECHNA VISION 11489 WOODSIDE AVE. Santee, CA 92071 |
Product Code | HME |
CFR Regulation Number | 886.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-06 |
Decision Date | 1985-10-17 |